Executive Medical Director, Drug Safety
SF Bay Area
Are you looking to elevate you career to the next level in Drug Safety? A rapidly expanding biopharmaceutical company is looking for a talented Executive Medical Director, Drug Safety to join its rapidly expanding team. This company has received a tremendous amount of recognition for its innovative medicines and therapies in Oncology and has a promising pipeline to continue to expand. If interested in learning more don't hesitate to apply.
The Executive Medical Director, Drug Safety will be responsible for:
- Represents the PV group of the Drug Safety Department in the clinical development of assigned products/ combination projects in clinical development. For these products/projects the candidate reviews, prepares, and/or contributes to the safety sections of relevant documents (e.g. study protocol, informed consent, investigator brochure and Reference Safety Information , clinical study reports, summary of clinical safety..)
- Reviews and/or contributes to the aggregate reports (PSUR/PBRER, DSUR, 6-monthly SUSAR listing report)
- Defines and performs analyses on safety signals of assigned products/projects
- Leads the labeling activities for the safety sections of the assigned product/indication (e.g. CCSI, USPI)
- Leads the creation of responses to safety questions from Regulatory Agencies for the assigned products/projects, and reviews and/or contributes to responses for safety questions for non-assigned products/projects
- Contributes to the Safety Medical Teams for meetings associated with assigned products/indications
- Assesses the quality and accuracy of ICSR medical review, leads the weekly medical review meetings, provides ad hoc guidance to the ICSR medical reviewers
- In collaboration with the Operations team and medical reviewers, defines medical strategy and training to obtain quality medical content narratives in individual ICSRs
- In collaboration with the Operations team and medical reviewers, develops a strategy to obtain and track important medical follow-up information on individual ICSRs of interest (including direct follow-up with reporters)
- Is the designated Subject Matter Expert for medical questions related to processing ICSRs in partner audits and regulatory inspections
Ideal candidates will have:
- MD Degree
- At least 3+ years of clinical experience post-residency, and at least 7-10 years of experience in the PV/Drug Safety Department of a pharmaceutical/biotechnology company.
- PV experience in Oncology is a plus.
