We are seeking a Local Qualified Person for Pharmacovigilance (Local QPPV/LQPPV) ensures drug safety and regulatory compliance within, acting as the main liaison between the Marketing Authorisation Holder (MAH) and local health authorities. Key responsibilities include managing adverse event reports, submitting safety data, monitoring local legislation, and maintaining audit readiness.
Core Responsibilities
- Regulatory Liaison: Acts as the primary contact point for local regulatory authorities regarding pharmacovigilance (PV) requests, safety enquiries, and, 24/7 availability.
- Adverse Event Management: Oversees the collection, processing, evaluation, and reporting of Adverse Drug Reactions (ADRs) to local competent authorities.
- Local Compliance: Ensures local PV activities comply with national regulations, which may differ from EU or global standards.
- Safety Monitoring & Reporting: Monitors local safety data, handles literature searches, and manages local Risk Management Plan (RMP) implementation.
- Audits and Inspections: Manages and participates in local, internal, or authority inspections, including handling Corrective and Preventive Actions (CAPA).
- Product Quality Complaints (PQCs): Often responsible for handling PQCs and Medical Information Enquiries (MIEs).
Required Skills and Qualifications
- Education: A degree in pharmacy, medicine, or life sciences.
- Knowledge: In-depth knowledge of local and international drug safety legislation (e.g., EU-GVP).
- Experience: Proven experience (10+ years) in pharmacovigilance, PV systems management, and regulatory compliance.
- Skills: Strong attention to detail, organizational abilities, and proactive management of safety data.
