Description
We are seeking an Associate Medical Safety Director to join our Lifecycle Safety Medical team. The successful candidate will participate in all aspects of Medical Safety activities, providing and maintaining PV and risk management expertise to internal and external stakeholders.
Responsibilities:
- Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile
- Lead signal detection and analysis, including signal detection strategy, frequency, and timing
- Provide medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, and other regulatory documents
- Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up
- Provide safety oversight and contribution for label development, review, and updates
- Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
- Represent safety and clinical data review findings during internal and external stakeholder meetings
- Provide medical safety support, contribution, and attendance at Safety Governance and other Meetings as needed
Requirements:
- A medical degree from an accredited and internationally recognized medical school
- Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research
- Experience in Signal detection, Aggregate reports and Risk management
- Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing