- Develop and lead product safety surveillance strategies and identify emerging clinical safety issues.
- Conduct routine and ad hoc reviews of safety data and monitor for safety signals.
- Oversee expedited safety reporting, including medical review of ICSRs and SUSARs.
- Provide medical safety guidance to clinical study teams, investigators, and internal stakeholders.
- Lead the preparation of safety-related aggregate reports and regulatory documents such as Investigator's Brochures, DSURs, and RMPs.
- Represent Pharmacovigilance in correspondence and meetings with the FDA and global regulatory authorities.
- Oversee pharmacovigilance vendors and ensure quality and performance standards are met.
- Support inspection readiness and represent the function during audits and due-diligence activities.
Risk Management