Company/Legal Entity:- Novartis Hltcr Shared Services Ind. Position Title:- Pharmacovigilance Scientist, Work Location:-Hyderabad,

Job ID	180540BR
Position Title	Pharmacovigilance Scientist
Division	NBS
Business Unit	PLS NBS
Country	India
Work Location	Hyderabad
Company/Legal Entity	Nov Hltcr Shared Services Ind
Functional Area	Research & Development
Job Type	Full Time
Employment Type	Regular
Job Description	Prepare aggregate safety reports assigned to PLSS with 100% quality/ review assigned PSUR and related safety reports for Novartis Pharma marketed product portfolio. Support preparation of Standard Operating Procedures (SOP), templates and business guidance writing. Maintain compliance of safety reports preparation within PLSS by timely delivering high quality documents according to the defined timelines. Processing and evaluation of Serious Adverse Events / Post Marketing Adverse Events to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality. Ensure accurate and consistent coding of medical history, drugs and adverse event terms. Assess adverse event reports for seriousness, causality and expectedness as per applicable labeling, consulting the Medical Safety Expert whenever needed. Screen literature articles for databasing or rejection. Co-author, along with the Medical Safety Physicians, all required regulatory aggregate reports (USPR/ PSUR, PADERs, PBRERs, AR and BD) - collecting, organizing and presenting the data. Contribute towards preparation of SOPs, process related documents and product guidance documents. Collaborate with Electronic Data Management to reconcile Serious Advense Events between the Clinical and Safety databases to meet joint accountabilities to enable the locking of Clinical database. Represent PLSS at internal and external meetings of DS&E /customers as needed. Alert the Medical Safety Physicians to potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of product as appropriate. Participate in cross-functional teams on safety matters/DS&E special projects relating to investigational and marketed drugs. 1. Successful and timely delivery of aggregate reports to DRA for submission to Health Authorities 2. Quality of deliverables according to established directives. 3. Compliance with Internal and External regulations and procedures.
Minimum requirements	Master Degree in life Sciences/Pharmacy/ English More than 6 years of experience in Drug Safety (PV), preferably in aggregate report writing apply:- https://sjobs.brassring.com/TGWEbHost/jobdetails.aspx?jobId=2400695&PartnerId=13617&SiteId=5260