Drug Safety Specialist

Role Description The Drug Safety Specialist is a full-time, on-site role based in Ludhiana. This role focuses on monitoring, evaluating, and reporting drug safety data to ensure compliance with applicable regulations and internal standards. Day-to-day tasks include reviewing adverse event reports, coordinating with clinical and medical teams, maintaining safety databases, and preparing documentation for regulatory submissions. The Drug Safety Specialist will collaborate with cross-functional stakeholders to support risk assessment, pharmacovigilance activities, and continuous improvement of safety processes. The role also involves staying current with relevant guidelines and assisting in training team members on drug safety procedures.
Qualifications
Knowledge of Regulatory Requirements and experience in Regulatory Affairs related to drug safety and pharmacovigilance.
Background in Pharmacy and/or Medicine with an understanding of drug mechanisms, indications, and safety profiles.
Experience with Clinical Trials, including handling safety data, adverse event reporting, and trial documentation.
Strong analytical and documentation skills, with attention to detail and accuracy in data handling and reporting.
Ability to interpret medical and scientific information and communicate clearly with technical and non-technical stakeholders.
Proficiency in using medical or safety databases and standard office software tools.
Bachelor’s degree or higher in Pharmacy, Medicine, Pharmacology, or a related life sciences field.
Demonstrated ability to work collaboratively in a multidisciplinary environment and manage time effectively.
Familiarity with national and international pharmacovigilance guidelines is an advantage.

Work arrangement
No