24 Oct
|
Unichem Laboratories
|
India
24 Oct
Unichem Laboratories
India
Experience- 5 to 10 Years
Qualification- M.B.B.S. in Any Specialization / Medical-MS/MD in Any Specialization
RESPONSIBILITIES
Triage of adverse event reports in Argus Database
Medical review of adverse event reports in Argus Database
Causality assessment of adverse event reports in Argus Database
Signal management activities
Medical review of aggregate reports
SmPC and PIL evaluation, comparison, and updates as required
DESIRED SKILLS
Expert knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, GVP Modules; respective EU Clinical Trial Directive etc.)
Experience with ICSR review and assessment
Strong interpersonal skills and the ability to be adaptable in varying settings
Positive attention to detail and decision-making skills.
📌 Medical Reviewer Pharmacovigilance Mumbai (India)
🏢 Unichem Laboratories
📍 India