Senior Clinical Safety Physician (Sr Dir / Exe Dir)
Department: PV
Report to: VP, PV Head
Location: US Remote
MAIN REPONSIBILITIES:
- To partner with clinical development to support robust safety assessment of investigational products.
- To work with clinical development to develop the benefit-risk evaluation in aggregate safety reports.
- To manage safety topics under evaluation and ensure efforts are aligned to meet global pharmacovigilance and risk management strategies for assigned products
- To be accountable for scientific strategy for safety related documents including CTD components, Risk Management Plans (RMP) and Periodic Safety Update Reports (PSUR)), and for ensuring that the safety sections are medically and scientifically appropriate.
- To lead safety surveillance activities such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgment in review of aggregate data and individual cases.
- To provide recommendations for pharmacovigilance actions, and to review and approve labeling, the RMPs, pharmacovigilance strategies and risk minimization activities.
- To review and approve safety summaries and analyses of safety related data for regulatory documents, aggregate reports, and summaries in support of regulatory filings
- To review and approve Reference Safety Information (RSI) and product labeling (Company Core Safety Information (CCSI), Investigator Brochure (IB), and national labels).
- To contribute to regulatory responses for CSR, ISS, IND, and NDA submissions.
QUALIFICATIONS:
- MD degree or equivalent
- Clinical practice experience or additional post-graduate medical training.
- Solid experience (>10 years) in clinical safety, pharmacovigilance and/or risk management
- Previous experience of US NDA submission in oncology therapeutic area is preferred.
- Familiar with global drug development and pharmacovigilance guidelines (US FDA, PMDA, EMA, ICH).
- Expert in the development and maintenance of risk management plans (RMPs) and REMS and oversight of critical safety issues and benefit-risk assessments.
- Expert in providing medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and ad hoc periodic reports and ensuring the overall quality of documents.
- Demonstrated cross-functional leadership, strong communications, and analytic skills.
