Pharmacovigilance Job at Syneos Health, India
Looking to build a career in pharmacovigilance with a global CRO? This Safety & PV Specialist I and II role offers hands-on experience in drug safety and regulatory reporting. You will work on ICSRs, safety databases, and global pharmacovigilance processes. The Pharmacovigilance Job at Syneos Health Careers in India is ideal for professionals with prior PV experience seeking career growth. Night shift flexibility is required, making it suitable for candidates comfortable with global operations.
About the Company:
Syneos Health is a leading, fully integrated life sciences services organization that supports drug development and commercialization. With a strong global presence, the company partners with innovators to accelerate clinical and commercial success. It has contributed to a significant percentage of FDA-approved drugs and EMA-authorized products, making it a key player in the healthcare and clinical research industry.
Job Details:
- Job Role: Safety & PV Specialist I and II
- Location: Hyderabad / Gurugram / Pune (Office-based)
- Job Type: Full-time
- Shift: Night Shift
- Experience Required: Minimum 2.6 Years (PV Specialist I) and Minimum 4 Years (PV Specialist II)
- Eligibility: Immediate/Early joiners preferred
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.
- 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.
- 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 this Job:
- BDS / BMS / MBBS
Skills Required:
- Strong knowledge of pharmacovigilance processes
- Experience in ICSR processing and MedDRA coding
- Understanding of global safety regulations (GCP, ICH, GVP)
- Attention to detail and data accuracy
- Good communication and teamwork skills
- Ability to work in night shifts and manage deadlines
- Proficiency in safety databases and tracking systems
Benefits of the Pharmacovigilance Job:
- Opportunity to work with a global CRO
- Exposure to international drug safety projects
- Career growth and training opportunities
- Inclusive and supportive work environment
- Competitive compensation and rewards programs
- Experience with advanced pharmacovigilance systems and processes
