Senior Regulatory Pharmacist (PV Lead & RA Support)
Zuellig Pharma · Singapour
Job description
About the role
Zuellig Pharma is seeking a Senior Regulatory Pharmacist to act as the local Pharmacovigilance (PV) point of contact and subject‑matter expert. The role combines leadership of patient safety activities with support for Regulatory Affairs operations to ensure compliance with Singapore statutory requirements.
Key responsibilities
- Serve as the primary PV liaison for the Health Sciences Authority (HSA), internal teams and multinational clients.
- Manage end‑to‑end logging, triage, assessment and reporting of adverse events, product quality complaints and medical inquiries within mandated timelines.
- Review and execute Pharmacovigilance Agreements, lead audit and inspection readiness, and close CAPA plans.
- Perform monthly AE/PQC reconciliations, coordinate literature monitoring and deliver internal PV training.
- Support local commercial compliance with Singapore regulations (HSA, MOH, NEA, CNB) and process special access permits.
- Maintain product registration, licensing status and material classifications in SAP.
- Act as backup Responsible Person for HSA wholesale/import licences and controlled drug licences as needed.
Required profile
- Bachelor of Pharmacy or equivalent degree.
- Registered and actively licensed pharmacist with the Singapore Pharmacy Council.
- Minimum 3 years experience in Pharmacovigilance and/or Regulatory Affairs.
- Strong knowledge of Singapore HSA regulations, Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP).
- High ethical standards, meticulous attention to detail and effective stakeholder management.
Required skills
- SAP ERP
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Published 1 month ago
Expires 3 weeks from now
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Zuellig Pharma
Singapour
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