As a Sr. PV Alliance Management Specialist, 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 Haleon marketed and investigational products.
Role Responsibilities
- 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
Why you
- Experience with Positive 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
Basic Qualifications
- B.Pharma/M.Pharma/ PHD or M.Sc with relevant experience background
Preferred Qualifications
- 7+ years of Pharmacovigilance experience.
- Strong experience in SDEA (Safety Data Exchange Agreements) management.
- Experience in PV authoring/writing activities.
- Good understanding of PV Exposure and Safety Data Exchange processes.
- Experience in stakeholder/partner management within global PV operations.
Location: Hyderabad
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