Wipro Limited (NYSE: WIT) is a leading global information technology, consulting, and business process services company. With over 75 years of innovation, Wipro delivers cutting-edge solutions in healthcare, IT, and life sciences, ensuring compliance with global regulatory standards.
Job Description: Drug Safety Physician
Wipro is hiring Drug Safety Physicians (MBBS/MD) for its Pharmacovigilance (PV) team in Pune. This role involves reviewing biomedical literature, assessing adverse drug reactions (ADRs), and ensuring compliance with global PV regulations.
Key Responsibilities:
✔ Review published biomedical literature to identify individual case safety reports (ICSRs) and non-case reports per regulatory guidelines.
✔ Perform relevancy assessments to determine if articles meet case report definitions.
✔ Provide training & guidance to junior team members on case inclusion criteria.
✔ Collaborate with Subject Matter Experts (SMEs) to ensure compliance with ICH-GCP, GVP, and FDA/EMA guidelines.
✔ Perform narrative writing, MedDRA coding, and causality assessments.
✔ Assist in signal detection, risk management, and aggregate report writing as needed.
Required Skills & Competencies:
✅ Sound knowledge of Pharmacovigilance (PV) regulations (ICH, GVP, FDA, EMA)
✅ Narrative Writing & MedDRA Coding expertise
✅ Strong understanding of pharmacology & adverse drug reactions (ADRs)
✅ Excellent verbal & written communication skills
✅ Ability to work in a fast-paced, compliance-driven environment
How to Apply?
Interested candidates can share their updated resume at:
📧 varsha.kamalapurkar@wipro.com
