Company: STADA Vietnam/STADA Pymepharco
Location: HCMC - Viettel Tower
Position: Regulatory & Pharmacovigilance Manager
Reporting line: Head of Regulatory Affairs
Open for candidates with +8 years experience with minimum 1 year experience in Regulatory-PV at manager level (experience in PV and clinical trials, BE studies is a plus) and has good command of English
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 minimum 1 year experience in Regulatory-PV at manager level (experience in PV and clinical trials, BE studies is a plus)
- Strong project management and planning skills. Ability to work cross-functionally and lead initiatives.
- Good command of English (verbal & non-verbal)
Main Responsibilities:
Regulatory Affairs
- Prepare, review and acquire approval for registration dossiers for products (Medicine, food supplement, cosmetic, medical device) as assigned in company RA plans.
- Assist in the design and execution of clinical trials, BE studies for registration dossier purpose.
- 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.
*Note: By clicking the Submit Application button, you agree to allow STADA Pymepharco to collect and process your personal data for recruitment purpose.
