MBBS Graduate Fresher Jobs in Karnataka Bangalore- Drug Safety Physician OpeningsNovember 12th, 2012 Posted by Shane
Job Position: Drug Safety Physician
Number of Posts: 10
Name of the Company: Synowledge PV Services India Pvt Ltd
Job Location: Bengaluru/Bangalore
Experience: 0 to 5 yrs
- Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
- Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
- Perform triage of cases and determine seriousness and relatedness across products as assigned
- Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
- Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
- Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
- Conduct assessment of litigation cases across products as assigned
- Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
- Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
- Acquire and maintain knowledge of applicable Global Health Authority regulations
- Perform any other drug safety related activities as assigned.
Details of the Company:
Synowledge specializes in providing drug safety, regulatory affairs and related IT services to small, mid, and large sized pharmaceutical, biotechnology and medical device companies. Our comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to meet all of our clients’ needs. Founded in 2006, Synowledge is headquartered in Stamford CT, USA with operational facilities across the United Kingdom, Columbus, Ohio, Bangalore and Mysore, India.
Apply: Email your cv to firstname.lastname@example.org
Contact Person: Sharath Chandra T