M.Pharma from a recognized university or equivalent. M.Sc. Biotechnology / Microbiology from a recognized university or equivalent. Working knowledge in the area of Biotechnology.
Degree in life Sciences, Health or Biomedical Sciences Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc., or relevant work experience in Pharmacovigilance.
Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority.
GBS TMF Team Lead is responsible for the strategic oversight, coordination, and leadership of the GBS TMF Services, ensuring high standards in Trial Master File management and inspection readiness for all assigned clinical trials.
Postgraduate degree in Science/ Pharmacology/ Life Sciences/ Regulatory Science/ Public Health from a recognised University with atleast 6 years of relevant work experience
55% marks in B.Sc / M.Sc. (Bioscience/ Life Sciences). Experience Preference will be given to candidates possessing knowledge or experience in Microsoft Excel.
Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code and enter data. Be fully competent to perform all steps within the case-handling processing.
Hetero is one of worlds leading producers of key Active Pharmaceutical Ingredients and generic formulations with presence in 140+ countries and backed by 30 years of experience in the pharma sector.