Sr. Scientist, Drug Safety (Pharmacovigilance)

Key Responsibilities:

• Provide advanced scientific oversight of ICSR and clinical trial SAE evaluation, ensuring medical accuracy, regulatory reportability, and consistency across global development programs.
• Lead the development of high-quality case narratives and guide the scientific preparation of regulatory ready case submissions, including SUSARs, in alignment with global reporting requirements.
• Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk–benefit assessments for investigational and marketed products.

Qualifications:

• PharmD or PhD in scientific field with 6+ years of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience.
• Working knowledge of global PV regulations and guidelines applicable to clinical development (e.g., FDA, EMA, ICH, GCP).
• Strong analytical skills, attention to detail, and comfort working across multiple programs.