Senior Director, Medical Safety and Pharmacovigilance
We are currently searching for a Senior Director, Medical Safety and Pharmacovigilance to review adverse event reports and provide support to the Clinical Development, Regulatory, Biometrics, Clinical Operations and Clinical Science groups. The role will provide medical consultation to the Product Development Teams and Clinical Development and Regulatory Team (CDRT) and make contributions to process improvements. This position reports into the Vice President, Clinical Development.
- Performs medical review of individual case safety reports. Reviews adverse event reports, adhering to standard operating procedures for medical assessment of individual case safety reports providing medical safety assessment and pharmacovigilance comment.
- Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IRB)/ ethics committee (EC) queries.
- Oversee, prepare, and/or review aggregate safety review documents (e.g., DSUR, PBRER) and safety sections of relevant clinical trial documents (e.g., protocols, clinical study report [CSR], investigator brochure [IB], informed consent form [ICF]) and regulatory filings.
- Lead the evaluation & management & documentation of signals emerging from any data source. Develop strategy for signal evaluation (e.g., case-series, literature review, HA/ claims database).
- Provides medical consultation including literature review and management on an ad hoc basis
- Makes contributions to process improvement, particularly with adverse event processing and operational aspects of medical review
- Supports medical review group with other ad hoc projects
- Lead safety activities and benefit-risk strategies for assigned compound(s)/ program. Establish and chair the product Safety Management Team(s) as required.
- Assist the team and senior management in all forms of issue management
- Requires an MD/DO degree or equivalent
- Completion of an accredited medical or surgical residency program is required. Board certification is preferred.
- Demonstrates an excellent scientific/clinical and analytical knowledge base, with ability to assess individual case safety reports and understand the safety/medical implications
- Demonstrates independence in effectively managing projects
- Excellent written and verbal communication skills