Senior Pharmacovigilance Associate/ Drug Safety Specialist

Job Title: Senior Pharmacovigilance Associate / Drug Safety Specialist Company: Forward Life Pvt Ltd Industry: Clinical Research Organization (CRO) Location: Hyderabad Department: Pharmacovigilance / Drug Safety Reporting: PV Manager / Head of Pharmacovigilance Employment Type: Full-time, On-site Salary: As per Company norms Preferred Candidates: Male/Female Shift: Rotational shifts (mandatory) Agreement: Candidate must agree to a 2-year employment agreement About the Company Forward Life Pvt. Ltd. (FLPL) is a rapidly growing Clinical Research Organization offering services in Clinical Operations, Pharmacovigilance, Regulatory Affairs, and Quality. We operate with global standards, strategic leadership, and high professional ethics. Job Purpose To ensure patient safety by monitoring, collecting, assessing, and reporting adverse drug reactions (ADRs) and other safety information in compliance with global pharmacovigilance regulations and company policies, while supporting advanced pharmacovigilance activities and mentoring junior team members. Key Responsibilities Collect, process, review, and perform quality checks of individual case safety reports (ICSRs) from healthcare professionals, patients, and literature. Perform data entry and medical coding of adverse events using safety databases (e.g., Argus/ARISg). Conduct case evaluation, narrative writing, medical review, and quality review of ADR reports. Support and contribute to aggregate report preparation (PBRERs, PSURs, DSURs) as required. Participate in signal detection, risk assessment, and benefit–risk evaluation activities. Ensure compliance with global PV regulations (ICH, EMA, FDA, CDSCO). Liaise with cross-functional teams including clinical, regulatory, and quality departments. Support internal and external audits, inspections, and CAPA implementation. Provide guidance and knowledge sharing to junior pharmacovigilance associates when required. Maintain up-to-date knowledge of drug safety regulations and guidelines. Required Qualifications Education: Pharm D (Doctor of Pharmacy) – mandatory. Knowledge of pharmacology, drug safety, and clinical practices. Understanding of pharmacovigilance guidelines (ICH E2A–E2E, GVP modules). Strong written and verbal communication skills. Proficiency in MS Office and safety databases preferred. Key Skills & Competencies Attention to detail and accuracy. Analytical and critical thinking. Ability to work under deadlines. Team player with strong interpersonal skills. Willingness to learn and adapt to regulatory changes. Experience 5–10 years experience in Pharmacovigilance. Hands-on experience in case processing, narrative writing, safety database management, and aggregate safety reporting. Prior experience in pharmacovigilance, clinical research, or regulatory affairs will be an added advantage. Employment Type: Full-time Job Types: Full-time, Permanent Benefits: • Health insurance • Provident Fund Work Location: In person