Drug Safety Officer
Chandigarh, PunjabFull-timeJunior levelPosted 2 months ago
Pharma role at Randstad in Chandigarh and Punjab. Needs an MBBS.
About the role
Performing medical review of Individual Case Safety Reports (ICSRs); preparation of aggregate reports; performing activities related to signal management for client pharmaceutical products, medical review of narratives for Clinical Study Reports (CSRs), according to client guidelines and Standard Operating Procedures (SOPs) and applicable regulatory requirementsFunctional
What you'll do
- Contributing (authoring and/or medical review) to aggregate reports like Periodic Safety
- Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs)
- Development Safety Update Reports (DSURs), Addendum to Clinical Overview (ACO)
- Internal Periodic Safety Review (IPSR), Risk Management Plans (RMPs)] or other
- Scheduled or unscheduled reports, as required
What you need
- Pharmacovigilance
- Transcription
- PowerPoint
- SOP writing
- Communication