Local Person for Pharmacovigilance (LPPV)

Position Summary: 

Our client is seeking an experienced Local Person for Pharmacovigilance (LPPV) to support pharmacovigilance activities and ensure compliance with local regulatory requirements and Good Pharmacovigilance Practices (GVP). 

The LPPV will act as the local pharmacovigilance contact for national regulatory authorities and support the Qualified Person for Pharmacovigilance (QPPV) and Marketing Authorization Holder (MAH) in maintaining oversight of product safety and regulatory compliance. 

Key Responsibilities 

• Ensure compliance with local pharmacovigilance regulations and GVP requirements 
• Act as the local pharmacovigilance contact for regulatory authorities 
• Support adverse event collection, processing, and safety reporting activities 
• Ensure timely submission of Individual Case Safety Reports (ICSRs) to local health authorities 
• Support Risk Management Plans (RMPs) and local risk minimization activities 
• Collaborate with Regulatory, Medical, Quality, and PV teams 
• Support PV audits, inspections, and inspection readiness activities 

Qualifications & Profile 

• Bachelor's or master's degree in medicine, Pharmacy, Life Sciences, or related discipline 
• Minimum 5+ years of Pharmacovigilance experience 
• Knowledge of local PV regulations, safety reporting, and GVP requirements 
• Familiarity with PV databases, MedDRA coding, and safety reporting systems 
• Strong communication, organizational, and problem-solving skills 
• Ability to work independently and collaboratively