Clinical Safety Lead

About the job

We are seeking a Safety Physician to join our growing Pharmacovigilance team. You will be responsible for the medical evaluation and oversight of safety data across clinical development programs, ensuring compliance with regulatory requirements. The ideal candidate will have a strong foundation in pharmacovigilance and clinical safety, and will be responsible for the analysis, coding, interpretation, and reporting of safety data. This position offers the opportunity to work at the intersection of clinical development, regulatory affairs, and medical safety, and includes collaboration with cross-functional teams and external partners.

Responsibilities

• Monitor participant safety during clinical trials by reviewing adverse events, SAEs, and providing medical assessments.
• Conduct medical review of individual case safety reports (ICSRs), including SAEs, ADRs, and SUSARs including assessment of causality, expectedness, and severity of adverse events.
• Perform aggregate safety data analysis and contribute to aggregate safety reports (e.G., DSURs, PSURs / PBRERs, RMPs) and safety narratives.
• Support safety-related regulatory submissions and responses (e.G., INDs, NDAs, BLAs).
• Ensure timely and accurate reporting of SAEs and safety signals to regulatory authorities.
• Review experimental protocols and informed consent documents;

prepares, reviews, and edits presentations regarding safety review committee meetings.

present at Data Safety Monitoring Board (DSMB) meetings.

represent PV in cross-functional teams.

Education

Qualifications :

Experience

Skills