Clinical Research Associate @ Emcure Pharmaceuticals, Pune

Evaluation of Non serious/Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality.
Experience in preparation of clinical overviews and non-clinical overviews for Europe regulatory and emerging markets.
Experience in preparation of Summary of Product Characterstics (SPC) and Patient Information leaflet (PIL) for Europe regulatory
Experience in preparation of periodic safety update reviews (PSUR) and risk management plans (RMP).
Experience in collection of literature required for preparation of protocols, filing NOC and answering regulatory queries.
Designing protocol, Patient Information Sheet, Informed consent form, Case Record Form
Experience: 1 to 4 yrs.
Posts: 4
Posted on: 06 Feb
B.Pharm, MBBS, M.Pharm, PG Diploma
Candidate should have the knowledge of Clinical research activities like : Clinical Overviews , Pharmacovigilence activities and should be familier with
Schedule Y, ICH, GCP guidelines
ICMR guidelines.
Regulatory guidelines of US FDA & European Union
Designing protocol, Patient Information Sheet, Informed consent form, Case Record Form
Recruiter Name:Mr. Omkar Badave
Reference Id:UNIT18/CLINICAL

APPLY HERE