Mayank Barg

About Mayank Barg

I am an experienced Manager with a rich background spanning 15+ years in the fields of Pharmacovigilance, Aggregate Reporting (Innovator & Generics) and Signal Detection using AI. Holding a Master\'s degree in Pharmaceutical Technology, I currently serve as a Senior Manager specializing in Aggregate Reporting (PV) and Literature Review.My professional journey has seen me take on diverse roles, including Manager, Assistant Manager, Senior Medical Writer (Safety Associate – Aggregate Reporting), and Pharmacovigilance Associate. In these capacities, I have amassed a wealth of hands-on experience in various aspects of Pharmacovigilance, including Aggregate Reporting, RMP, Signal Detection and ICSR case processing ( Drugs and Device). My expertise extends to the management of Aggregate Reports and Individual Case Safety Reports (ICSR) projects. I possess a deep understanding of Aggregate reporting processes, SOP preparations, Compliance and Quality monitoring while encompassing authoring, reviewing, and submission of periodic safety reports such as PBRER, PSUR, DSUR, PADER, ACO/AdCO, RMPs using Veeva vault, Veeva safety, RIM etc. Additionally, I have successfully handled Signal Detection documents (SOV-SER-SSAR) and managed ICSR processing and submissions from end to end.My approach to work is characterized by quick learning, a thirst for knowledge, and a commitment to smart work infused with innovative thinking. I am proud of my previous affiliations with reputable organizations such as Sciformix Technologies (Covance), Bioclinica, Cognizant Technologies, and Tata Consultancy Services, where I honed my skills and made meaningful contributions to the field of Pharmacovigilance.I am passionate about continuously expanding my knowledge and skills in Pharmacovigilance and related areas, and I am dedicated to delivering high-quality results in every project I undertake. My comprehensive experience and commitment to excellence make me a valuable asset in the realm of Pharmacovigilance and related fields.

Experience

1. Global Safety Sr Manager

   Amgen

   Sep 2025 — Present · Hyderabad, IN

Education

• Royal college of pharmacy and health sciences, Berhampur, Orissa

  Master’s Degree, Pharmaceutics and Drug Design

  2010 — 2012

• Lal Bahadur Shastri College of Pharmacy

  B. Pharmacy, Pharmaceutical Sciences

  2006 — 2010

Skills

• Case Processing
• CRO
• Gcp
• Biotechnology
• Medical Writing
• Regulatory Affairs
• Lifesciences
• Regulatory Requirements
• Pharmaceutical Industry
• Sop
• Fda
• CRO Management
• Glp
• Validation
• Ich-Gcp
• Software Documentation
• Pharmacology
• U.s. Food and Drug Administration (Fda)
• Good Laboratory Practice (Glp)
• Management
• Pharmaceutics
• Good Clinical Practice (Gcp)
• Clinical Data Management
• Clinical Trials
• Standard Operating Procedure (Sop)
• Meddra
• Clinical Research
• Oncology
• Healthcare
• Pharmacovigilance
• Gmp
• Life Sciences