India's DMPLOI - Jobs & Networking AppSyneos Health is inviting applications for the position of Safety & Pharmacovigilance (PV) Specialist I at its Gurgaon, Haryana office. This is an excellent opportunity for professionals looking to build or advance their career in Pharmacovigilance and Drug Safety with one of the world’s leading life sciences organizations.
If you have experience in Individual Case Safety Report (ICSR) processing, safety data management, MedDRA coding, regulatory compliance, and pharmacovigilance operations, this opportunity could be the perfect next step in your career.
Job Details
- Company: Syneos Health
- Job Role: Safety & PV Specialist I
- Location: Gurgaon, Haryana, India
- Job Type: Full-Time
- Department: Pharmacovigilance (Drug Safety)
About Syneos Health
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization that supports customers throughout the drug development and commercialization journey. With more than 25,000 professionals worldwide, the company delivers innovative clinical, medical affairs, and commercial solutions that accelerate the delivery of life-changing therapies to patients across the globe.
The organization promotes continuous learning, career growth, collaboration, and an inclusive work environment where employees are empowered to make a meaningful impact on global healthcare.
Key Responsibilities
As a Safety & PV Specialist I, you will be responsible for:
- Processing Individual Case Safety Reports (ICSRs) according to SOPs and project requirements.
- Entering and maintaining safety information in pharmacovigilance databases.
- Triaging ICSRs and evaluating case completeness, accuracy, and regulatory reportability.
- Coding adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and standard drug dictionaries.
- Preparing comprehensive case narratives.
- Following up on missing or incomplete safety information.
- Supporting expedited regulatory safety reporting.
- Maintaining safety tracking and documentation.
- Performing literature screening and safety reviews.
- Managing drug coding and maintaining drug dictionaries.
- Validating and submitting xEVMPD product records.
- Supporting SPOR and IDMP-related activities.
- Identifying and managing duplicate safety cases.
- Conducting quality review of ICSRs.
- Maintaining Trial Master File (TMF) documentation and Pharmacovigilance System Master File documentation where applicable.
- Ensuring compliance with SOPs, ICH-GCP, GVP guidelines, global regulatory requirements, and sponsor-specific procedures.
- Participating in internal and external audits.
- Collaborating effectively with project teams and stakeholders.
Required Skills
Candidates with the following knowledge and skills are encouraged to apply:
- Pharmacovigilance and Drug Safety Operations
- Individual Case Safety Report (ICSR) Processing
- MedDRA Coding
- Safety Database Management
- Narrative Writing
- Literature Screening
- Regulatory Safety Reporting
- Drug Coding
- xEVMPD Validation
- SPOR & IDMP Activities
- Quality Review of ICSRs
- Good Clinical Practice (GCP)
- ICH Guidelines
- Good Pharmacovigilance Practices (GVP)
- Strong analytical and communication skills
- Attention to detail and commitment to regulatory compliance
Why Join Syneos Health?
Syneos Health offers an environment where employees can grow professionally while contributing to meaningful healthcare innovations. Benefits include:
- Career development and progression opportunities
- Comprehensive technical and therapeutic training
- Supportive leadership and mentoring
- Inclusive and collaborative work culture
- Global exposure across life sciences projects
- Recognition and rewards programs
- Opportunity to work with leading pharmaceutical and biotechnology companies
Job Location
Gurgaon, Haryana, India
How to Apply
Interested candidates who meet the eligibility criteria can apply through the official Syneos Health Careers portal. Ensure your resume highlights your pharmacovigilance experience, ICSR processing expertise, regulatory knowledge, and relevant safety database skills before submitting your application.
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