TCS Hiring Aggregate Safety Report Writer
Experience-4 to 10 Years
Work Location: Mumbai / Pune
Preferred Qualification:
- 15 years full time education
- Graduate/Postgraduate in Computer Science/Computer Application/Physics/Math’s or equivalent. Graduate/Postgraduate in Life Sciences/Pharmacy or other with relevant experience. Domain expertise would be added advantage.
JD:
Minimum of 3 years’ experience in authoring (safety sections of aggregate reports or authored signal assessment reports) and review of PSURs/PBRERs, DSURs, PADERs, ACOs etc.
· Candidate should have knowledge of applicable regulatory guidelines including GVP modules, ICH and Title 21 CFR guidelines
· Candidate should have sound medical knowledge
· Candidate should have excellent communication skills
· Candidate should have excellent stakeholder management skill