[제약/QA] Senior Manager - PV

A foreign pharmaceutical company is looking for a Senior Manager – PV. The chosen applicant will handle various aspects of pharmacovigilance, including implementing training programmes, developing SOPs, and monitoring drug safety.

Responsibilities:

• Act as a general liaison with API-PV and other DSOs to exchange information and procedures
• Implement, organise, and document a PV Awareness training programme for relevant staff
• Develop and maintain local SOPs that accurately reflect PV procedures
• Develop drug safety monitoring plans for local clinical trials sponsored by the Affiliate.
• Collect and follow-up on Adverse Events (AEs) from various sources
• Create and Quality Control (QC) Affiliate relevant form for Individual Case Safety Reports (ICSRs)
• Conduct reconciliations against Medical Information Enquiries (MIEs), Product Quality Complaint (PQC) databases, and other sources
• Submit ICSRs and aggregated reports to relevant local Authority as necessary
• Monitor local legislative requirements and inform API-PV to maintain a complete overview of relevant guidelines on PV
• Support API-PV in case of safety issues

Requirements:

• Bachelor’s degree or above in pharmacy, medical, life sciences, chemistry or similar
• More than 10 years of experience in R&D or a medical role
• More than 5 years of experience in PV role
• Demonstrated knowledge of domestic PV regulations
• Relevant external pharmaceutical professional training with an advanced professional degree

About the Company:

A global pharmaceutical company committed to improving the health of people around the world. The company is committed to improving the health and quality of life of people through cutting-edge research, advanced therapies, and strong partnerships within the medical community.

Keywords:

제약, 의료, R&D, 약효, 국제

Job Ref: 8W9IUX