Pharmacovigilance Lead

Vacancy an international Pharm company.

Key Responsibilities:

• Ensure inspection readiness and act as the local safety point of contact (including QPPV).

• Oversee case management, signal detection, safety reporting, risk communication, and PV documentation.

• Support patient-centric initiatives, product launches, and data-driven safety insights.

• Collaborate with internal and external partners to influence safety policy and healthcare improvements.

• Lead local safety strategy, ensuring alignment with therapeutic area goals and business priorities.

• Actively contribute to innovation, digital transformation, and scalable patient safety solutions.

• Management of Individual Case Safety Reports, Signal Detection & Management for Local Products

• Management of Aggregate Safety Reports, Pharmacovigilance Agreements, and Safety Data Exchange Agreements

• Risk Management and Safety Communication (e.g., Direct Healthcare Professional Communication, emerging safety issues)

• Studies, Programs and Other business activities with implications to patient safety and PV Compliance (e.g., interventional CT, NIS, PASS, PAES, MAP, PAA, CUP, PTAP)

• Safety Labeling and PV Commitments

• Local Pharmacovigilance System Master File (where applicable)

Requirements:

• 3–5 years of experience in pharmacovigilance, ideally within a local affiliate.

• Background in life sciences, public health, or similar; MD/HCP qualification.

• Deep PV system knowledge, cross-functional collaboration skills.

• Strong understanding of local healthcare environment and patient safety needs.

• Fluent in English.