Clinical - Medical Safety Assessment Physician Mature Products Contractor - TechDigital Corporation
Trenton, NJ 08648
About the Job
Role is 50% onsite
Manager is open to candidate sitting at any of the following locations:
PPK, LVL, Summit (NJ) as well as San Diego and Brisbane (CA)
Position Summary
· Lead safety activities and benefit-risk strategies for assigned Client compounds/ program and chair the product Safety Management Team(s).
· Oversee, Prepare, and/or Review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.
· Lead team in the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation and document outcome.
· Lead safety labeling activities for assigned products/ program. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/ Provide input at cross-functional labeling team meetings and provide regional safety labeling support.
· Lead process improvement projects. Assist the MSA Therapeutic Area (TA) Head/Lead in developing and maintaining state-of-the-art PV processes and procedures within Client R&D and WWPS.
· Support the EU Qualified Person for Pharmacovigilance (PV) or other regional or local Qualified Person for PV relative to issues relating to assigned products.
· Ensure that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements and Client cost effectiveness goals.
· Promote collegiality and teamwork among peers. Mentor/Support colleagues as a positive change agent.
Position Responsibilities General Product Support
· Lead safety activities and benefit-risk strategies for assigned Client compounds and chair the product SMT(s).
· Oversee, Prepare, and/or Review aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER))
· Lead team in evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.
· Lead safety labeling activities for assigned products. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/ Provide input at cross-functional labeling team meetings and provide regional safety labeling support.
· Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
Postmarketing Support
· Act as the safety lead for assigned marketed compounds and support global postmarketing safety activities and submissions.
· Provide medical safety, benefit-risk input for safety aggregate reports, product renewal submissions, postmarketing study documents and reports, responses to HA queries.
· Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
· Lead safety signal evaluation & management. Prepare and Review reports on safety signals (ie, Safety Topic Reviews/ Signal Reports) and ad hoc regulatory responses.
· Provide postmarketing safety study guidance to other groups including epidemiology and medical affairs
· Ensure safety labeling adequately reflects emerging postmarketing safety profile.
Department Activities
· Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
· Assist the team and senior management in all forms of issue management and crisis management.
· Liaise with all TA staff and maintain an effective and collaborative patient safety team.
· Provide input to strategic plans for safety differentiation of Client products.
· Prepare and Provide training to Client employees on product safety profiles/issues.
· Act as WWPS liaison for assigned products with Client functions (Legal, Client, Operations, Marketing, etc.).
· Support manufacturing quality. Co-Author integrated health hazard assessments.
· Develop communications of safety data & interpretation to Client and external parties, globally.
Degree Requirements
MD required. Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.
Experience Requirements 5+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) at global level and focused on mature/established drugs is strongly preferred.
Key Competency
· Understanding of the drug development process.
· Knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
· Proficient ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
· Understanding of regulatory requirements for safety assessment and action.
· Strong scientific analytical reasoning skills.
· Ability to work on multiple projects in parallel.
· Excellent attention to detail.
· Behavioral competencies necessary to work and lead within a complex matrix environment.
· Excellent verbal and written communication skills.
Manager is open to candidate sitting at any of the following locations:
PPK, LVL, Summit (NJ) as well as San Diego and Brisbane (CA)
Position Summary
· Lead safety activities and benefit-risk strategies for assigned Client compounds/ program and chair the product Safety Management Team(s).
· Oversee, Prepare, and/or Review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.
· Lead team in the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation and document outcome.
· Lead safety labeling activities for assigned products/ program. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/ Provide input at cross-functional labeling team meetings and provide regional safety labeling support.
· Lead process improvement projects. Assist the MSA Therapeutic Area (TA) Head/Lead in developing and maintaining state-of-the-art PV processes and procedures within Client R&D and WWPS.
· Support the EU Qualified Person for Pharmacovigilance (PV) or other regional or local Qualified Person for PV relative to issues relating to assigned products.
· Ensure that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements and Client cost effectiveness goals.
· Promote collegiality and teamwork among peers. Mentor/Support colleagues as a positive change agent.
Position Responsibilities General Product Support
· Lead safety activities and benefit-risk strategies for assigned Client compounds and chair the product SMT(s).
· Oversee, Prepare, and/or Review aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER))
· Lead team in evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.
· Lead safety labeling activities for assigned products. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/ Provide input at cross-functional labeling team meetings and provide regional safety labeling support.
· Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
Postmarketing Support
· Act as the safety lead for assigned marketed compounds and support global postmarketing safety activities and submissions.
· Provide medical safety, benefit-risk input for safety aggregate reports, product renewal submissions, postmarketing study documents and reports, responses to HA queries.
· Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
· Lead safety signal evaluation & management. Prepare and Review reports on safety signals (ie, Safety Topic Reviews/ Signal Reports) and ad hoc regulatory responses.
· Provide postmarketing safety study guidance to other groups including epidemiology and medical affairs
· Ensure safety labeling adequately reflects emerging postmarketing safety profile.
Department Activities
· Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
· Assist the team and senior management in all forms of issue management and crisis management.
· Liaise with all TA staff and maintain an effective and collaborative patient safety team.
· Provide input to strategic plans for safety differentiation of Client products.
· Prepare and Provide training to Client employees on product safety profiles/issues.
· Act as WWPS liaison for assigned products with Client functions (Legal, Client, Operations, Marketing, etc.).
· Support manufacturing quality. Co-Author integrated health hazard assessments.
· Develop communications of safety data & interpretation to Client and external parties, globally.
Degree Requirements
MD required. Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.
Experience Requirements 5+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) at global level and focused on mature/established drugs is strongly preferred.
Key Competency
· Understanding of the drug development process.
· Knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
· Proficient ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
· Understanding of regulatory requirements for safety assessment and action.
· Strong scientific analytical reasoning skills.
· Ability to work on multiple projects in parallel.
· Excellent attention to detail.
· Behavioral competencies necessary to work and lead within a complex matrix environment.
· Excellent verbal and written communication skills.
Source : TechDigital Corporation