Syneos Health is hiring Safety & Pharmacovigilance Specialist I for its clinical safety operations in Gurugram, India. This opportunity is ideal for professionals with 2.5โ4 years of pharmacovigilance experience, particularly in ICSR processing, Product Quality Complaint (PQC) handling, and safety database management.
The role offers hands-on exposure to global pharmacovigilance case processing, regulatory safety reporting, safety data management, and compliance with international PV regulations. Candidates with experience in Argus Safety or ARISg databases, MedDRA coding, and clinical trial safety reporting will find this position particularly suitable for advancing their pharmacovigilance careers.
Syneos Health is a globally recognized biopharmaceutical solutions organization operating in more than 110 countries, supporting clinical development, medical affairs, and commercialization for pharmaceutical and biotechnology companies.
Job Overview
- Position: Safety & Pharmacovigilance Specialist I
- Company: Syneos Health
- Location: Gurugram, India
- Employment Type: Full Time
- Experience Required: 2.5 โ 4 Years
- Department: Clinical Safety / Pharmacovigilance
Key Responsibilities
ICSR Processing and Safety Case Management
The Safety & PV Specialist will manage end-to-end Individual Case Safety Report (ICSR) processing and ensure compliance with global pharmacovigilance requirements.
Key activities include:
- Processing ICSRs according to SOPs and safety management plans
- Entering safety data into Argus or ARISg pharmacovigilance databases
- Coding adverse events and medical information using MedDRA
- Evaluating cases for regulatory reportability
- Writing comprehensive narrative summaries
- Identifying and resolving duplicate safety cases
- Performing quality checks and case review
Product Quality Complaint (PQC) Case Handling
- Manage Product Quality Complaint safety cases
- Evaluate PQC events linked with safety signals
- Collaborate with safety teams to ensure proper documentation and follow-up
Regulatory Safety Reporting
- Support expedited safety reporting to regulatory authorities
- Assist with xEVMPD submissions and MedDRA coding
- Maintain documentation for Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
- Ensure compliance with ICH, GCP, and GVP guidelines
Literature Review and Safety Monitoring
- Perform scientific literature screening for adverse events
- Maintain drug dictionaries and coding activities
- Support pharmacovigilance audits and inspection readiness
Collaboration and Stakeholder Communication
- Work with cross-functional teams including clinical operations, regulatory affairs, and safety teams
- Maintain strong professional relationships with internal and external stakeholders
Required Qualifications
Candidates applying for this Pharmacovigilance Specialist job should meet the following requirements:
Education
Eligible degrees include:
- B.Pharm
- M.Pharm
- PharmD
- BDS
- BMS
- MBBS
(B.Sc / M.Sc candidates are not eligible for this role.)
Experience
- 2.5โ4 years of pharmacovigilance experience
- Minimum 1 year experience handling Product Quality Complaint (PQC) cases
- Experience in medical research safety cases
Technical Skills
- Hands-on experience with Argus Safety or ARISg safety databases
- Knowledge of MedDRA coding
- Understanding of clinical trial phases IIโIV safety reporting
- Familiarity with global pharmacovigilance regulations
- Proficiency in Microsoft Office tools
Benefits of Working at Syneos Health
Employees joining Syneos Health gain access to a wide range of career development opportunities including:
- Global exposure to clinical safety and pharmacovigilance programs
- Structured career progression and professional training
- Competitive compensation and rewards programs
- Collaborative work culture supporting diversity and inclusion
- Opportunities to work on clinical trials across multiple therapeutic areas
Syneos Health has contributed to the development of 94% of recently approved FDA drugs and 95% of EMA-authorized products, highlighting its strong presence in the global pharmaceutical industry.
How to Apply
