clinical Safety Scientist
3 days ago
TCS is hiring for Clinical Safety Scientist
Job Location – Chennai
Experience Range – 5 to 9 Years
Skillset Required – Aggregate Report, DSR, PSUR.
Educational Qualification(s) Required – Any Life Science Graduate
Roles & Responsibilities
Provide mentorship, oversight and training of less experienced colleagues.
Have a good understanding of all in scope processes.
Contribute to all signal management activities with medical expertise, i.e. contribute to detection, validation, DSR strategy and SME review, from time-to-time author parts of DSRs e.g. conclusion.
Confidently participate in report kick-off meetings and other meetings, as necessary.
Review of Clinical Study Reports (CSRs) safety sections and narratives for CSRs or health authority requests.
Provide expert medical input to aggregate reports and other processes.
Support Health Authority requests with medical expertize, including review and authoring of critical parts as/if necessary.
Lead or contribute to process improvement and technology / innovation activities.
Participate in internal and external audits and inspections, as required
Location
Chennai
Job Function
BUSINESS PROCESS SERVICES
Role
Executive
Job Id
382793
Desired Skills
Medical Regulatory
Desired Candidate Profile
Qualifications : BACHELOR OF PHARMACY, BACHELOR OF SCIENCE (B.Sc), MASTER OF PHARMACY, MASTER OF SCIENCE
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