Safety & Pharmacovigilance Specialist I Pharmacovigilance

Safety & Pharmacovigilance Specialist I Pharmacovigilance Jobs in Gurugram | Syneos Health Location: Gurugram, India Company: Syneos Health Job Type: Full-Time Department: Pharmacovigilance / Clinical Safety / Drug Safety Operations Experience Required: 02 years (Freshers with relevant pharmacovigilance knowledge may apply) Job ID: 25107956 About the Company Syneos Health is a globally established life sciences and biopharmaceutical solutions organization that supports pharmaceutical, biotechnology, and healthcare innovators across the complete drug development and commercialization lifecycle. With a strong global presence and deep expertise in clinical development, regulatory operations, and drug safety, Syneos Health offers exceptional career opportunities for professionals in pharmacovigilance and clinical research. This role is ideal for candidates looking to establish or grow their careers in pharmacovigilance, adverse event case processing, medical coding, regulatory reporting, and global safety operations. Job Overview Syneos Health is hiring a Safety & Pharmacovigilance Specialist I for its Gurugram office. This is an excellent opportunity for freshers and early-career professionals interested in entering the field of pharmacovigilance and drug safety. The selected candidate will support global safety operations involving ICSR case processing, MedDRA coding, literature review, expedited reporting, safety database management, duplicate case detection, regulatory documentation, and compliance-driven pharmacovigilance workflows. Candidates with academic backgrounds in life sciences, pharmacy, nursing, medicine, biotechnology, or clinical research are encouraged to apply. Key Responsibilities ICSR Case Processing Process Individual Case Safety Reports (ICSRs) as per pharmacovigilance SOPs and project safety plans. Review incoming adverse event reports for completeness, quality, consistency, and regulatory reporting eligibility. Perform triage and classification of safety cases. Enter case data accurately into validated pharmacovigilance safety databases. Follow up on incomplete safety cases and manage query resolution. Medical Coding & Safety Data Management Perform MedDRA coding for adverse events, indications, medical history, and clinical findings. Code concomitant medications and treatment-related information. Maintain drug dictionaries and coding standards. Handle manual recoding of unresolved product or substance information. Support duplicate ICSR identification and reconciliation. Narrative Writing & Regulatory Reporting Prepare medically structured safety narratives. Assist in expedited adverse event reporting in accordance with global regulatory requirements. Maintain case tracking and reporting documentation. Literature Surveillance & Regulatory Support Conduct literature screening for safety-related adverse event cases. Review published medical literature for reportable pharmacovigilance data. Support xEVMPD validation and submission processes. Contribute to SPOR / IDMP pharmacovigilance compliance activities. Quality & Compliance Perform quality review of safety cases and documentation. Maintain Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) documentation. Ensure compliance with: Good Pharmacovigilance Practices (GVP) International Council for Harmonisation (ICH) guidelines Good Clinical Practice (GCP) Global drug safety regulations Internal SOPs and Work Instructions Collaboration & Audit Support Work closely with internal safety teams, project stakeholders, and external partners. Participate in audits, inspections, and process quality initiatives. Apply updated regulatory intelligence in day-to-day safety reporting activities. Required Qualifications Bachelors or Masters degree in: Pharmacy Life Sciences Biotechnology Nursing Clinical Research Medicine Allied Healthcare disciplines Basic understanding of: Pharmacovigilance workflows ICSR processing Adverse event reporting MedDRA coding Drug safety compliance Strong written communication and documentation skills High attention to detail and analytical thinking Ability to work in a deadline-driven, compliance-focused environment .