Pharmacovigilance Job at Syneos Health, India
Want to advance your Pharmacovigilance career with a leading global life sciences organization? If you have extensive experience in Individual Case Safety Report (ICSR) processing and Quality Check (QC), this is an excellent opportunity to join Syneos Health Careers as a Sr Safety & PV Specialist. The Pharmacovigilance Job in India offers exposure to global pharmacovigilance operations, regulatory compliance, safety data management, and clinical development programs.
About the Company:
Syneos Health is a leading fully integrated life sciences services organization dedicated to accelerating customer success across the drug development and commercialization continuum. The company partners with pharmaceutical, biotechnology, and healthcare innovators to deliver clinical, commercial, and consulting solutions that improve patient outcomes worldwide. With over 25,000 professionals globally, Syneos Health has contributed to 94% of all Novel FDA-approved drugs over the past five years, supported 95% of EMA-authorized products, and conducted more than 200 studies across 73,000 clinical sites involving over 675,000 trial participants. The company is committed to innovation, diversity, career development, and delivering high-quality healthcare solutions.
Job Details:
- Job Title: Sr Safety & PV Specialist
- Job Type: Full-Time
- Work Mode: Office-Based
- Job Locations: Hyderabad, Gurugram, Pune
- Department: Pharmacovigilance (PV)
- Preferred Candidates: Immediate or early joiners
- Mandatory Skill: ICSR Case Processing with Quality Check (QC) experience
Key Responsibilities:
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
- Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
- Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
- Enters data into safety database.
- Codes events, medical history, concomitant medications, and tests.
- Compiles complete narrative summaries.
- Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
- Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Maintains safety tracking for assigned activities in the Pharmacovigilance Job in India.
- Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
- Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
- Manual recoding of un-recoded product and substance terms arises from ICSRs.
- Identification and management of duplicate ICSRs.
- Activities related to SPOR / IDMP.
- Quality review of ICSRs.
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate at Syneos Health Careers.
- Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
- Fosters constructive and professional working relationships with all project team members, internal and external.
- Participates in audits as required/appropriate.
- Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
Educational Requirements for the Pharmacovigilance Job:
Candidates should possess any one of the following qualifications:
- BDS
- BMS
- MBBS
Skills Required for the Pharmacovigilance Job:
- Individual Case Safety Report (ICSR) Processing
- Quality Check (QC) of Safety Cases
- Pharmacovigilance Operations
- MedDRA Coding
- Drug Coding
- Safety Database Management
- xEVMPD Validation and Submission
- SPOR and IDMP Knowledge
- Literature Screening
- Narrative Writing
- Safety Data Review
- Regulatory Compliance
- GCP, GVP, and ICH Guidelines
- Trial Master File (TMF) Management
- Adverse Event Processing
- Case Triage
- Attention to Detail
- Analytical Skills
- Communication Skills
- Team Collaboration
- Time Management
- Problem-Solving Skills
