Senior Pharmacovigilance Specialist – Case Processing
ProPharma · Makati
Job description
About the role
ProPharma is seeking a Senior Pharmacovigilance Specialist to lead daily case processing of adverse event reports from clinical trials and post‑marketing sources. You will ensure accurate coding, seriousness assessment, and timely follow‑up while supporting client communications and regulatory compliance.
Key responsibilities
- Oversee and perform daily processing of adverse event cases, including MedDRA coding and determination of seriousness and expectedness.
- Conduct case follow‑up activities, gather additional information, and create or review case narratives.
- Provide client notifications as required and highlight discrepancies to senior PV staff.
- Maintain up‑to‑date knowledge of global safety regulations and perform peer reviews for quality and consistency.
- Mentor and train junior staff, develop training materials, and support PV deliverables as a subject‑matter expert.
Required profile
- Bachelor’s degree in life sciences (advanced degree, RN, RPh, PharmD preferred).
- Minimum three years of experience in pharmacovigilance case processing.
- Strong written and verbal communication, high attention to detail, and ability to work independently and within multidisciplinary teams.
Required skills
- MedDRA coding.
- Working knowledge of PV systems such as Oracle Argus Safety and ARISg.
- Familiarity with PV Systems and intermediate pharmacovigilance knowledge.
What we offer
- A diverse and inclusive workplace that encourages innovation and collaboration.
- Opportunities for professional growth through mentorship and training.
- Engagement with cutting‑edge biotech, medical device, and pharmaceutical projects.
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Published 1 month ago
Expires 6 days from now
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ProPharma
Makati
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