Pharmacovigilance Lead
- Компания: АНКОР Центральная Азия
- Город Казахстан, Алматы
- Зарплата:
- Размещено: 2025-07-08 07:49:34
Описание
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.