Regulatory Clinical & PV MANAGER (MACA)

Company: STADA Vietnam/STADA Pymepharco

Location: HCMC - Viettel Tower

Position: Regulatory Clinical & Pharmacovigilance Manager

Reporting line: Head of Regulatory Affairs

Benefit:

• 100% SHUI contribution on probation time
• 15 days annual leave/year
• Healthcare Insurance covered for 2 dependents
• Birthday, Tet, holidays...bonus
• Friendly, open and comfortable MNC working environment
• Other benefits following current labor law

Key Requirements

• Pharmacist degree or equivalent
• At least 8 years experience with at least 1 year experience in Regulatory Clinical-PVat manager level (experience in PV and clinical trials, BE studies is a plus)
• Have ever on behalf of Vietnam market on PV reporting with regional is a plus point
• Strong project management and planning skills. Ability to work cross-functionally and lead initiatives.
• Good command of English (verbal & non-verbal)

Main Responsibilities:

Regulatory Clinical Affairs

• Lead in the design and execution of clinical trials, BE studies for registration dossier purpose. Prepare, review and acquire approval for registration dossiers for products as assigned in company RA plans.
• Maintain, archive and report all technical documentation, databases, or systems.
• Support development of Standard Operating Procedures (SOP), work instructions or policies.
• Ensure adherence of all processes implemented in local regulatory guidelines, Code of Conduct, and compliance policy.

Pharmacovigilance

• Act as Local PV person for Vietnam within STADA's global System.
• Being the direct report to the EU QPPV (Director Global Medical Affairs/Corporate Pharmacovigilance) and providing information on all PV activities and safety issues to EU QPPV on an ongoing basis.
• Maintain the local PV Unit at STADA-Pymepharco, implement all requirements and processes from STADA's global PV policy and local regulations into local SOPs, as well as ensure alignment of PV strategy with business objectives.
• Fulfil all PV requirements outlined in the STADA global PV SOPs, according to the national legislation and PV obligations deriving from PV Agreements with contractual partners (third-party MAHs). Respond to medical inquiries from healthcare professionals and ensure accurate and timely dissemination of medical information.

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