Drug Safety Physician – Medical Governance & Oversight

About the role

Azurity Pharmaceuticals is seeking a highly motivated Drug Safety Physician to provide medical governance and oversight for its pharmacovigilance activities. This senior position ensures that the sponsor retains full medical accountability for safety decisions while working with an external safety vendor.

Key responsibilities

• Provide medical governance oversight of vendor‑performed case assessments and safety decisions.
• Review complex, serious, and medically significant Individual Case Safety Reports (ICSRs).
• Oversee signal detection, evaluation activities, and aggregate reporting (PBRER, PSUR, DSUR).
• Supervise literature surveillance reviews conducted by the vendor.
• Ensure appropriate benefit‑risk evaluation across all products.
• Participate in vendor governance meetings, reviewing medical KPIs and trends.
• Act as the medical safety representative during audits and regulatory inspections.
• Deliver medical training and guidance to internal PV staff as needed.
• Maintain sponsor’s medical accountability for all PV decisions.

Required profile

• MD or equivalent medical degree.
• 7+ years of experience in Pharmacovigilance or Drug Safety.
• Proven experience with signal management and aggregate reporting.
• Experience in outsourced PV models preferred.
• Strong knowledge of global PV regulations (FDA, EMA, MHRA).
• Inspection and audit experience.
• Ability to provide high‑level medical judgment and governance oversight.

Required skills

• Pharmacovigilance
• Signal detection and evaluation
• Aggregate safety reporting (PBRER, PSUR, DSUR)
• Regulatory compliance (FDA, EMA, MHRA)

What we offer

• Opportunity to lead medical safety governance at a growing specialty pharma.
• Collaborative environment with a focus on patient‑centric innovation.
• Inclusive workplace and equal opportunity employment.