Sr Safety

Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding Job Title: Senior Safety & Pharmacovigilance (PV) Specialist Discover more Health Libraries Computer Science Company: Syneos Health Location: Gurugram / Hyderabad, India (Office-based) Job ID: 25107898 Employment Type: Full-time Department: Safety & Pharmacovigilance Operations Experience Required: Minimum 6+ years of Pharmacovigilance experience with strong expertise in ICSR case processing, quality review (QC), safety database management, and regulatory safety reporting. Discover more Pharmacy Job Dictionaries & Encyclopedias Occupational Health & Safety Education: B.Pharm / M.Pharm / BDS / BMS / MBBS (B.Sc/M.Sc not eligible) Salary Package: 1222 LPA (Estimated as per current market standards for Senior Safety & PV Specialist roles in India; final compensation depends on ICSR processing expertise, QC experience, regulatory exposure, and interview performance.) Role Summary The Senior Safety & PV Specialist will manage end-to-end Individual Case Safety Report (ICSR) processing activities, ensure quality and regulatory compliance, perform safety data review, and support global Pharmacovigilance operations according to ICH-GCP, GVP, and regulatory requirements. Key Responsibilities ICSR Case Processing & Safety Database Management Enter and manage safety case information in Pharmacovigilance quality and tracking systems. Process ICSRs according to: Company SOPs Safety Management Plans Regulatory requirements Perform ICSR triage and evaluate: Completeness Accuracy Regulatory reportability Enter safety data into PV databases. Code: Adverse events Medical history Concomitant medications Laboratory tests Safety Data Review & Quality Control Perform Quality Control (QC) review of ICSRs. Ensure accuracy, consistency, and compliance of safety reports. Identify missing information and generate follow-up queries. Track query resolution until completion. Identify and manage duplicate safety cases. Perform manual recoding of un-coded product and substance terms. Regulatory Safety Reporting Support preparation and submission of expedited safety reports. Ensure timely and accurate regulatory submissions. Apply global safety reporting requirements and regulatory intelligence. Maintain compliance with: FDA regulations EMA requirements ICH guidelines GVP guidelines Medical Coding & Literature Review Perform literature screening and safety review activities. Conduct: MedDRA coding Drug coding Medical terminology review Maintain drug dictionaries and coding standards. Support xEVMPD product record validation and submissions. Perform indication coding using MedDRA. SPOR / IDMP Activities Support activities related to: SPOR data management Identification of Medicinal Products (IDMP) Ensure product and substance data accuracy. Documentation & Compliance Ensure safety documents are filed correctly in: Trial Master File (TMF) Pharmacovigilance System Master File (PSMF) Participate in: Internal audits Client audits Quality reviews Maintain compliance with: SOPs Work Instructions GCP ICH Guidelines GVP Regulations Global drug/biologic/device regulations Required Technical Skills Individual Case Safety Report (ICSR) Processing ICSR Quality Control (QC) Pharmacovigilance Operations Safety Database Management Adverse Event Coding MedDRA Coding Drug Dictionary Management Literature Screening Regulatory Safety Reporting xEVMPD Product Records SPOR / IDMP Knowledge TMF Filing GVP & ICH Guidelines Mandatory Skills Minimum 6 years of Pharmacovigilance experience Strong ICSR case processing experience Hands-on Quality Check (QC) experience mandatory Knowledge of global PV regulations Preferred Experience Experience with safety databases preferred CRO experience preferred. Global clinical trial safety experience. Exposure to post-marketing safety activities. Experience working with multinational pharmaceutical clients. Key Competencies Strong attention to detail. Excellent analytical and problem-solving skills. Ability to manage complex safety cases. Strong written and verbal communication skills. Ability to work independently and collaboratively. Good understanding of drug development processes. Work Location Gurugram / Hyderabad (Office-based) Career Opportunity Opportunity to work on global Pharmacovigilance programs. Exposure to international regulatory frameworks. Growth opportunities within Clinical Safety and PV operations. Collaboration with global pharmaceutical and biotech teams. Job Title: Senior Safety & Pharmacovigilance (PV) Specialist Discover more Health Libraries Computer Science Company: Syneos Health Location: Gurugram / Hyderabad, India (Office-based) Job ID: 25107898 Employment Type: Full-time Department: Safety & Pharmacovigilance Operations Experience Required: Minimum 6+ years of .