[Expressing of Interest] Pharmacovigilance Executive & Quality Executive
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Riachtanach:HealthTech
Pharmacovigilance Executive
Job Description: Recruit123 is helping our client to hire a Pharmacovigilance Executive. Our client is a growing pharmaceutical company seeking a Pharmacovigilance Executive to support drug safety monitoring and adverse event reporting across their product portfolio.
Responsibilities:
- Collect, process, and assess adverse event (AE) reports from healthcare professionals, patients, and internal teams
- Prepare and submit Individual Case Safety Reports (ICSRs) to HSA and relevant regional health authorities within required timelines
- Maintain and update the company's pharmacovigilance database and case tracking systems
- Support preparation of Periodic Safety Update Reports (PSURs) and other safety documentation
- Monitor literature and global safety databases for signals relevant to the company's product portfolio
- Assist in the implementation and maintenance of the Pharmacovigilance System Master File (PSMF)
- Liaise with regulatory affairs, medical, and quality teams on safety-related matters
- Support internal pharmacovigilance audits and inspections
Requirements:
- Degree in Pharmacy, Life Sciences, Nursing, or related field
- 1-4 years' relevant pharmacovigilance or drug safety experience (fresh graduates with strong life sciences background may be considered)
- Familiarity with HSA pharmacovigilance guidelines and ICH-GVP standards is an advantage
- Strong attention to detail and ability to manage case timelines accurately
- Good written and verbal communication skills
- Proficiency with safety database systems (e.g. ArisGlobal, Argus) is a plus
Name: Lian Cher Chieh (Steffan) UEN: 202511044R License No.: 25C2810EA Registration No.: R1217705