Sujeet Aher
Medical safety lead Biosimilars
- Role
- Medical Safety Lead Biopharmaceuticals at Sandoz
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Sujeet Aher
I am a qualified Medical Professional and a Postgraduate in Pharmaceutical Medicine with…
Experience
Medical Safety Lead Biopharmaceuticals
Apr 2021 — Present · Hyderabad, IN
Biosimilars: Immunosuppressants (TNF inhibitors, IL inhibitors) Hormones Global safety lead responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs (PSUR, DSUR, RMP)Provides safety support to the clinical development teams.Monitors the clinical safety of projects /products including activities such as literature review, evaluation of individual cases or signal detection, and responds to safety related questions appropriately.Identifies safety signals based on the review of solicited or unsolicited single cases. Performs signal detection, monitoring and evaluation of all safety signals. Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues.Prepares safety data for Health Authority review boards.
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