Minimum Bachelors degree in Life Sciences or Pharmaceutical Sciences required. Masters / other advanced degree or MBA in business administration or a scientific field preferred.
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.
Performs testing not only of raw materials and drug products, maintenance and calibration of analytical instruments, prepares standard and sample solutions and maintains appropriate records. Carry out checks of record documentation.
Develop stability study designs for new product development and sustaining product projects. Contribute to technical feasibility analysis of complex research and design concepts. Evaluate results relative to product requirements, definitions and/or program goals.