clinical Safety Scientist

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