Director | Head Of Medical Review@ Moderna
Cambridge, Massachusetts, United States
Grinu Oommen
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FlashIntel GPTGrinu Oommen is a highly experienced professional with over 10 years of expertise in the pharmaceutical/biotech industry. She has worked in various roles, including Director, Head of Medical Review at Moderna, Medical Director, Pharmacovigilance at Sage Therapeutics, and Safety Medical Doctor at Alexion Pharmaceuticals, Inc. Grinu has a strong background in clinical trials, pharmacovigilance, and regulatory submissions. She is skilled in areas such as biotechnology, drug development, and regulatory submissions. Grinu is based in the United States and has a proven track record in regulatory submissions and compliance with FDA regulations.
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About
Over 10 years of experience in the pharmaceutical/biotech arena as an industry physicianacross pharmacovigilance & clinical affairs, supporting regulatory filings, reviews, interactions,safety surveillance and risk management activities and audits.
Work Experience
Director | Head Of Medical Review
Biotechnology Research
Grinu Oommen's Professional Milestones
- Drug Safety Specialist (consultant) (2008-02-01~2009-10-01): Implementing effective safety strategies to minimize workplace accidents and promote a culture of safety, enhancing employee well-being.
- Associate Medical Director (2012-12-01~2016-02-01): Providing exceptional healthcare services to patients, ensuring compliance with regulatory requirements.
Education
Doctor Of Medicine,
Doctorates,
Nephrology
1996-2007Skill
Clinical Trials
Pharmacovigilance
Clinical Research
Clinical Development
Pharmaceutical Industry
Cro
Sop
Fda
Biotechnology
Drug Development
Gcp
Oncology
Medicine
Nephrology
Protocol
Drug Safety
Regulatory Submissions
Good Clinical Practice
Clinical Study Design
Pharmaceuticals
Cro Management
Standard Operating Procedure
Certification
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Grinu Oommen works for Moderna
Grinu Oommen's role in Moderna is Director | Head Of Medical Review
Grinu Oommen works in the industry of Biotechnology Research
Grinu Oommen's colleagues are Carlos Rivera,Michael Lonetto,Steve Zolud
Grinu Oommen's latest job experience is Director | Head Of Medical Review at Moderna
Grinu Oommen's latest education in Tver State Medical Academy
