GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders.
Post : SERM Scientist
Job description
As a Safety Pharmacovigilance Manager, you will be responsible for ensuring local regulatory obligations for clinical safety reports are met. This includes the appropriate collection, processing and reporting of adverse events (AEs) for GSK marketed and investigational products.
• Review, extract, and accurately enter Adverse Event (AE) data from marketed product, reports received from spontaneous and solicited sources including health professionals, sales representatives, consumers and drug information in accordance with defined case handling procedures
• Review, extract, and accurately enter all serious AE information from clinical trial reports in accordance with defined case handling procedures
• Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete and accurate narrative summaries
• Ensure proper coding of Adverse Event terms and other medical terms into the global AE database.
• Process and prepare reportable cases within applicable timelines including accurate determination of expectedness using the relevant core safety information
• Review and comment on protocols/Case Report Forms (CRFs) for established and new products/programs and develops appropriate data entry protocol specific guidelines
• Remain current with case handling standards, guidance documents and database technology.
• Demonstrate in-depth working knowledge of regulatory environment & ensures compliance with safety data exchange agreements
• Work with departmental teams in maintaining and upgrading the safety database
Candidate Profile
• Bachelor’s degree
• Experience with Good Clinical Practices (GCCP), clinical safety documentation and reporting of adverse events from clinical trials
• Experience with local regulatory requirements and pharmacovigilance methodology
• Experience working with the principles of data collection, manipulation and retrieval
• Advanced Degree in Life Sciences or medical field
• Previous experience as a Health care professional (e.g. pharmacist or nurse)
• Demonstrated planning and organizational skills
Additional Information
Location : Hyderabad, India
Qualification : Bachelor’s degree
Req ID : 251223
Industry Type : Pharma / Healthcare / Clinical research
End Date : 20th June, 2020
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