PV (pharmacovigilance) Specialist - Gurgaon - "D"

Designation	PV (pharmacovigilance) Specialist - Gurgaon - 1 Opening(s)
Job Description	AE/SAE Processing - To collect, process and follow up all local adverse events (AEs)/ serious adverse events (SAEs) from different sources (RHC call center, Healthcare professionals, sales and marketing personnel, patients, clinical trials, etc.); - To report the AE/SAE to the HA according to the India regulation (Schedule Y) within the required timeframe; - To log in cases into the local tracking system and transmit all reports in English to the GPV organization within the required timeframe;  - To archive all source documentation in accordance with Quality Control; - To file all Pharmacovigilance source documents and keep them available upon request by the HA. CIOMS Form Collecting  - To maintain the Baxter PSS data base; - To collect CIOMS form from GPV within the required timeframe. Document Archiving  - To maintain and archive the signed training record; - To maintain and archive the hardcopy of package insert; - To archive the PV related communication and correspondence
Desired Profile	Preferred: Clinical Medicine, Pharmacy or Science background, bachelor or above; At least 1 year relevant working experiences in pharmaceutical company;  Knowledge of the relevant PV regulations in India Good communication skills, ability to liaise with the different function involved: QA, RA, MA, marketing and sales team, etc.; Fluent in English both in oral & written. In addition, must have:  - Proactive and Can do attitude - Attention to detail - Time Management - Problem solving capability
Experience	0 - 1 Years
Industry Type	Medical / Healthcare / Hospitals
Role	Documentation/Medical Writing
Functional Area	Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Education	UG - B.Sc - Any Specialization, B.Pharma  PG - Any Postgraduate - Any Specialization, Post Graduation Not Required  DOCTORATE - Doctorate Not Required
Location	Gurgaon
Keywords	pharmacovigilance, adverse events reporting, AE Report, SAE report
Contact	Pallavi Gautam  Baxter India Pvt Ltd
Website	https:// baxter.in
Job Posted	02 Dec
Reference	PV-Spl-GGN		APPLY HERE