Senior Manager, PV Scientists - Ardelyx
Waltham, MA
About the Job
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA®(tenapanor) and XPHOZAH® (tenapanor), as well as early-stage pipeline candidates.
Purpose of the role:
Senior Manager, PV Scientist of Pharmacovigilance's main role is to ensure the process and evaluation of adverse events (AEs) received from clinical trials and/or post marketing sources to support drug development, postmarketing requirements and to monitor the safety and efficacy of products. This includes SAE quality check (QC), late case investigations, corrective and preventive actions (CAPA), distribution and regulatory submissions in a timely fashion to ensure compliance with local and global regulatory reporting.
Evaluate the quality of Individual Case Safety Reports (ICSRs), provide support to maintain and optimize the execution of the Quality Control Process for ICSRs including analysis, trending, monitoring, and follow-up oversight on the performance of the Quality Control process.
The pharmacovigilance scientist is responsible for case management handling and supports the writing of safety reports, e.g. PSUR's, DSUR's, Risk Management Plans, and Safety Signal Management. This role will serve as the SME for Pharmacovigilance related to company specific products. In addition, they will inform and advise CRO's/vendors regarding the safety of company products.
Position Responsibilities:
- Ensure timely case management activities for PV related to the collection, processing, and reporting/submission of safety information in accordance with all applicable regulatory requirements and internal procedures.
- Evaluate the quality of Individual Case Safety Reports (ICSRs); provide support to maintain and optimize the execution of the Quality Control Process for ICSRs
- Lead and conduct, independently and/or collaboratively, the preparation and authoring of safety reports for assigned products, such as PADER, PSURs/PBRER, DSURs.
- Facilitate signal management process for products and evaluate safety data and signals as part of ongoing pharmacovigilance activities.
- Contribute to the development and maintenance of Pharmacovigilance Site Master File (PSMF), Safety Management plan (SMP), Safety Data Exchange Agreement (SDEA's),
- Support inspection readiness and worldwide PV organization as it related to ICSR QC
- Support in maintaining, developing, and optimizing the overall QC process, including trending methodology, in collaboration with experts from other areas
- Participate in the continuous development, implementation and maintenance of the PV system including policies, Standard Operating Procedures (SOPs) to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices
- Other tasks as assigned or required
Position Requirements:
- Physician Assistant, Nurse practitioner, bachelor’s degree in nursing or with appropriate experience, in pharmacy, or related health care field.
- Must have at least a total of 7 years’ experience in pharmaceutical, Biotech, or CRO setting with at least 5 years in the Pharmacovigilance environment.
- Strong communication, writing and interpersonal skills are also required.
- Ability to analyze data, draw conclusions and make timely decisions
- Working knowledge of global Pharmacovigilance regulations
- Must have problem solving skills and ability to organize time effectively
- Proficient in Microsoft-based applications (i.e., Word, Excel, PowerPoint)
The anticipated annualized base pay range for this full-time position is $163,080 - $199,320. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
Source : Ardelyx