IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner. Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue
Preferred certifications include pharmacovigilance or drug safety training from recognized industry bodies such as DIA or similar professional organizations.
Bachelors Degree in Science with Chemistry or B.SC.(Pharmacy) of any University in India established or incorporated by or under a Central Act, a Provincial Act or a State Act or the institutions recognised by the University Grants Commission or an equivalent Qualification.
Maintain safety tracking systems and ensure timely completion of assigned activities and deliverables. Conduct MedDRA coding, drug coding, and maintenance of drug dictionaries as required.
Responsible for Regulatory Affairs activities in India and neighbouring markets, encompassing product registrations, regulatory submissions, approvals, renewals, lifecycle management, regulatory intelligence, and liaison with Health Authorities.
The Lead is expected to have extensive experience and provide thought leadership in Data Governance and Compliance, as well as on how the regulatory and pharmacovigilance (safety) systems, processes, and data interact and interface with other aspects of the Astellas information ecosystem.
Candidates should have passed their M.Sc. / M.Tech. / M.Pharm./ M.V.Sc./ 4 yrs graduate program or equivalent qualification in Life Sciences and allied subjects (Biochemistry/ Biotechnology/ Bioinformatics/ Biophysics/ Chemistry/ Microbiology) with at least 55%