Associate Specialist, Drug Safety
msd · IDN - Jakarta - Jakarta (Menara Astra)
Job description
About the role
The Associate Specialist, PV supports local pharmacovigilance processes, ensuring compliance with regulations and company policies. This temporary position works closely with internal teams and external partners to manage safety data and reporting.
Key responsibilities
- Assist with execution of local PV activities, including management of agreements, due diligence, and post‑approval safety monitoring.
- Handle day‑to‑day adverse event case management, including intake, translation, acknowledgment, follow‑up, and submission.
- Support local PV audits, inspections, and issue‑management activities, preparing corrective actions as needed.
- Maintain local PV procedures, controlled documents, and safety‑related archives.
- Participate in literature screening, risk‑minimization measure implementation, and business continuity plans.
Required profile
- Health, life science or medical science degree or equivalent experience.
- Fluency in English and proficiency in the local language.
- Good communication, organizational and time‑management abilities.
Required skills
- Action Plan Development
- Adverse Event Reporting
- Compliance Activities and Investigations
- Corrective Action Management
- Data Analysis, Management, Processing and Quality Assurance
- Document Controls
- Drug Safety Surveillance
- Pharmacovigilance and Pharmacology
- Regulatory Audits
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Published 1 jam yang lalu
Expires 1 bulan dari sekarang
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msd
IDN - Jakarta - Jakarta (Menara Astra)
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