Sameer Kalsekar

About Sameer Kalsekar

I am a pharmacovigilance physician with a total experience of around 18 years. I started my career with clinical practice which includes Intensive care management. Due to my core interest in clinical research, I joined the pharma industry and was involved in multiple roles with increasing responsibilities. Initially, I worked on early clinical development (phase 1 and 2) of products in oncology (Head and neck cancer, breast cancer and melanoma) indications. Majority of my experience is in pharmacovigilance domain where I worked on post marketed products across various therapeutic areas (oncology, cardiovascular, metabolic, women’s health, and dermatology) and biosimilar in clinical development (immuno-oncology and Metabolic). I am responsible for strategically leading pharmacovigilance activities of my assigned products as Global Program Safety Lead. Main experience includes safety chairing SMT, leading safety strategy and signal management activities for assigned portfolio, post marketing RMP commitments, response to complex health authority queries, participation in health authority meetings, participation in global brand team meetings, and presenting in Medical Safety Review Board meetings. I have supported complex biosimilar development products in the early development and post-approval phase. I have also participated in various due diligence and merger and acquisition activities as a safety lead. I was involved in various medical safety digital initiatives as a safety expert from medical function. For my contribution, I was awarded Novartis GDD star award for performance in 2017. I have co-authored “cardiovascular and skeletal safety of zoledronic acid in osteoporosis observational. Matched cohort study using Danish and Swedish health registries” published in Journal Bone (Feb 2020) and “Long‑Term Real‑World Post‑approval Safety Data of Multiple Biosimilars from One Marketing‑Authorization Holder After More than 18 Years Since Their First Biosimilar Launch” published in Drug Safety (October 2023).

Experience

1. Director Medical Safety Assessment

   Bristol Myers Squibb

   Sep 2024 — Present

Education

• Maharashtra University of Health Sciences

  MBBS, Medicine

  1999 — 2003

Skills

• Edc
• CRO
• Oncology
• Protocol
• Pharmacovigilance
• Pharmaceutics
• Medicine
• Pharmaceutical Industry
• Sop
• Clinical Development
• Regulatory Affairs
• Lifesciences
• Clinical Trials
• Clinical Research
• Regulatory Submissions
• Ich-Gcp
• Gcp
• Clinical Data Management
• Medical Writing