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Safety Surveillance Specialist/Physician
Work Remotely, India
Job Responsibilities :
- Perform medical interpretation of safety data with client oversight.
- Retrieve, analyze and interpret data from multiple sources (client systems, clinical trials, safety databases, literature, etc.).
- Determine and document the impact of identified safety issues on benefit-risk profile of affected client product(s).
- Lead authoring of assessment for identified signals as directed by client.
- Support the preparation of presentations of safety data and related information for client leadership and safety governance committees.
- Lead authoring of assigned sections of client Safety deliverables.
- Lead or support the preparation of regulatory safety requests.
- Other routine safety duties as assigned by client.
- Signal Detection and Assessment.
- Interpretation, summarization, and presentation of data and assigned safety deliverable documents.
- Assigned sections of client safety deliverable documents such as DSUR,PSUR,PADER,ACO,RMP,Clinical Overview,CSS,HHA.
Candidate Profile :
- Candidate should be M.Pharm, BDS, MDS, MBBS, MSc in Life Sciences.
- Should have 2-6 years of experience in Signal Management activities.
- Strong verbal and written communication skills, with ability to communicate effectively internally and with clients.
- Experience in Signal Detection, Signal Evaluation, and validation required.
- Candidate should be able to work in US timezone.