Associate Director, Postmarketing PV Case Management - United Therapeutics
Indianapolis, IN
About the Job
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
The Associate Global PV Case Management Director plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position strategizes and implements plans to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency, quality, and compliance impacts. This role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation, evaluation processes, and decisions to support the overall global safety surveillance program and proper management of benefit/risk of UTC products. This position can be remote in the continental US, or in our RTP, NC office and will include about 15% international and domestic travel.
+ Process Evaluation and Strategy: Evaluate, strategize, and execute process changes in response to regulatory updates, ensuring the effectiveness and efficiency of end-to-end commercial case processing; Initiate, plan, coordinate, and implement project plans to enhance process efficiencies and support business goals and objectives; Strategize and implement functional and department goals for the PM case processing operations team
+ Operational Oversight and Quality Assurance: Oversee day-to-day quality and compliance for vendor staff supporting adverse effect processing for commercial UT products, including PM GSD workflows; Maintain unified PM Case Management operating procedures and monitor systems to ensure all PM adverse effects are processed and submitted per UT SOPs and industry standards; Evaluate and sign off on all SOPs related to postmarketing case management activities
+ Regulatory Compliance and Guidance: Provide strategic guidance to ensures compliance with global regulations and guidelines for safety data collection, management, and reporting of postmarketing ICSRs; Remain current on global regulations, guidelines and industry best practices for end-to-end case management, ensuring compliance with global regulations and guidelines and timely processing of individual case reports
+ Stakeholder and Vendor Management: Act as the main point of contact and functional manager for day-to-day questions or issue escalation regarding PM case handling safety processes for internal stakeholders (i.e. PSRMMT, quality, regulatory), vendors, and external partners; Participate in strategic discussions with vendors and other team members of GPS & PV to ensure process compliance
+ Training and Development: Develop, facilitate, and provide training and training materials for AE, PC, and/or SRS collection and reporting of adverse effects in the commercial setting, in accordance with SOPs, global regulations, guidelines, and conventions; Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed)
+ Inspection and Audit Management: Act as the point of contact for inspections and audits related to end-to-end case processing activities for PM case types; Conduct root cause analysis of inspection or audit findings and ensure appropriate CAPA is in place to address the findings; Review and approve deviations/CAPAs for any PM ICSR-related activity as necessary
+ SOP and Procedural Document Management: Initiate and lead the development and implementation of new or revised SOPs; Update and maintain procedural documents to reflect current practice related to GPS/PV Operations
+ Reconciliation and Compliance Oversight: Oversee and resolve the PM reconciliation process, ensuring all discrepancies are addressed and compliance is maintained
+ Perform other duties as assigned
For this role you will need
Minimum Requirements
+ Bachelor’s degree in nursing, chemistry, biology, or a related field
+ 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a bachelor's degree or
+ 10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a master's degree or
+ 7+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a PhD/PharmD/MD/DO/or international equivalent
+ Previous experience using safety databases, preferably Argus
+ Strong written and verbal communication skills, including but not limited to the ability to communicate safety issues in a variety of formats required to meet the needs of the intended audience and contributors
+ End-to-end case processing, including data entry, QC, medical review, and regulatory submissions
+ Project management skills and ability to organize and deliver large, complex projects independently
+ Working knowledge of drug development processes and activities, including but not limited to having the ability to explain the legislative framework supporting all aspects of drug development & registration of medicines, ensuring their safety
+ Strong analytical thinking to diagnose common situations, gather and review relevant information, and recommend solutions
+ Ability to work effectively across functions; understands objectives, activities, and required contributions of internal partner functions
+ Ability to be adaptable and work effectively in ambiguous situations
+ Ability to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes
+ Working knowledge of MedDRA coding
+ Working knowledge of global regulations, guidelines and industry best practices for end-to-end case management for devices, biologics, and drug products
Preferred Qualifications
+ Master’s degree in chemistry, biology, or a related field or
+ Doctor of Philosophy (PhD) in chemistry, biology, or a related field or
+ Doctor of Pharmacy (PharmD) or
+ MD or DO or international equivalent or
+ 5+ years of experience in vendor management and oversight
+ 3+ years of product development and/or postmarketing drug experience
+ 2+ years of previous functional lead/people management experience
+ Prior PV management experience
The salary for this position ranges from $163,000 to $185,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities .
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
The Associate Global PV Case Management Director plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position strategizes and implements plans to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency, quality, and compliance impacts. This role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation, evaluation processes, and decisions to support the overall global safety surveillance program and proper management of benefit/risk of UTC products. This position can be remote in the continental US, or in our RTP, NC office and will include about 15% international and domestic travel.
+ Process Evaluation and Strategy: Evaluate, strategize, and execute process changes in response to regulatory updates, ensuring the effectiveness and efficiency of end-to-end commercial case processing; Initiate, plan, coordinate, and implement project plans to enhance process efficiencies and support business goals and objectives; Strategize and implement functional and department goals for the PM case processing operations team
+ Operational Oversight and Quality Assurance: Oversee day-to-day quality and compliance for vendor staff supporting adverse effect processing for commercial UT products, including PM GSD workflows; Maintain unified PM Case Management operating procedures and monitor systems to ensure all PM adverse effects are processed and submitted per UT SOPs and industry standards; Evaluate and sign off on all SOPs related to postmarketing case management activities
+ Regulatory Compliance and Guidance: Provide strategic guidance to ensures compliance with global regulations and guidelines for safety data collection, management, and reporting of postmarketing ICSRs; Remain current on global regulations, guidelines and industry best practices for end-to-end case management, ensuring compliance with global regulations and guidelines and timely processing of individual case reports
+ Stakeholder and Vendor Management: Act as the main point of contact and functional manager for day-to-day questions or issue escalation regarding PM case handling safety processes for internal stakeholders (i.e. PSRMMT, quality, regulatory), vendors, and external partners; Participate in strategic discussions with vendors and other team members of GPS & PV to ensure process compliance
+ Training and Development: Develop, facilitate, and provide training and training materials for AE, PC, and/or SRS collection and reporting of adverse effects in the commercial setting, in accordance with SOPs, global regulations, guidelines, and conventions; Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed)
+ Inspection and Audit Management: Act as the point of contact for inspections and audits related to end-to-end case processing activities for PM case types; Conduct root cause analysis of inspection or audit findings and ensure appropriate CAPA is in place to address the findings; Review and approve deviations/CAPAs for any PM ICSR-related activity as necessary
+ SOP and Procedural Document Management: Initiate and lead the development and implementation of new or revised SOPs; Update and maintain procedural documents to reflect current practice related to GPS/PV Operations
+ Reconciliation and Compliance Oversight: Oversee and resolve the PM reconciliation process, ensuring all discrepancies are addressed and compliance is maintained
+ Perform other duties as assigned
For this role you will need
Minimum Requirements
+ Bachelor’s degree in nursing, chemistry, biology, or a related field
+ 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a bachelor's degree or
+ 10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a master's degree or
+ 7+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a PhD/PharmD/MD/DO/or international equivalent
+ Previous experience using safety databases, preferably Argus
+ Strong written and verbal communication skills, including but not limited to the ability to communicate safety issues in a variety of formats required to meet the needs of the intended audience and contributors
+ End-to-end case processing, including data entry, QC, medical review, and regulatory submissions
+ Project management skills and ability to organize and deliver large, complex projects independently
+ Working knowledge of drug development processes and activities, including but not limited to having the ability to explain the legislative framework supporting all aspects of drug development & registration of medicines, ensuring their safety
+ Strong analytical thinking to diagnose common situations, gather and review relevant information, and recommend solutions
+ Ability to work effectively across functions; understands objectives, activities, and required contributions of internal partner functions
+ Ability to be adaptable and work effectively in ambiguous situations
+ Ability to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes
+ Working knowledge of MedDRA coding
+ Working knowledge of global regulations, guidelines and industry best practices for end-to-end case management for devices, biologics, and drug products
Preferred Qualifications
+ Master’s degree in chemistry, biology, or a related field or
+ Doctor of Philosophy (PhD) in chemistry, biology, or a related field or
+ Doctor of Pharmacy (PharmD) or
+ MD or DO or international equivalent or
+ 5+ years of experience in vendor management and oversight
+ 3+ years of product development and/or postmarketing drug experience
+ 2+ years of previous functional lead/people management experience
+ Prior PV management experience
The salary for this position ranges from $163,000 to $185,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities .
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Source : United Therapeutics