This office-based role suits experienced pharma professionals with 2.5–4 years in ICSR processing and PQC handling—ideal for pharma jobs in drug safety, regulatory compliance, and medical device vigilance.
About the Company
Syneos Health is a leading fully integrated biopharmaceutical solutions organization and CRO, dedicated to accelerating customer success through clinical development, medical affairs, and commercial insights.
With over 26,000 employees across 110+ countries, the company has supported 94–96% of recent FDA-approved novel drugs and a high percentage of EMA-authorized products. Recognized as a leader in pharmacovigilance operations by Everest Group, Syneos Health emphasizes innovation, regulatory compliance (GCP, ICH, GVP), diversity, and employee growth in a patient-centered, agile environment.
Job Details
- Company Name: Syneos Health
- Experience: 2.5 – 4 Years (minimum 1 year exclusive PQC handling required)
- Qualification: B.Pharm / M.Pharm / PharmD / BDS / BMS / MBBS (B.Sc / M.Sc not eligible)
- Location: Gurugram (Gurgaon), Haryana, India
- Work Type: Office-Based (Full-Time)
Job Description
Syneos Health is recruiting for the Safety & Pharmacovigilance Specialist I role, specializing in Medical Device safety and Product Quality Complaint (PQC) handling.
This position involves end-to-end Individual Case Safety Report (ICSR) processing, safety data management, and support for global regulatory reporting in pharmacovigilance for drugs, biologics, and devices.
Safety & Pharmacovigilance Specialist I – Medical Device & PQC
- Department: Pharmacovigilance / Drug Safety
- Market: Global (focus on medical devices, product quality, and post-marketing/clinical safety)
- Role: Safety & PV Specialist I
- Experience: 2.5–4 Years overall; minimum 1 year exclusive PQC case handling
- Education/Qualification: B.Pharm, M.Pharm, PharmD, BDS, BMS, MBBS
Skills/Qualifications
- Hands-on experience with Argus / ARISg safety databases
- Strong knowledge of global pharmacovigilance regulations, ICH guidelines, GVP, and reporting requirements
- Expertise in Product Quality Complaint (PQC) case processing
- Experience handling medical research-related safety cases
- Proficiency in MedDRA coding for adverse events, medical history, medications, and lab tests
- Understanding of clinical trial phases II–IV and/or post-marketing safety
- Excellent Microsoft Office skills
- Attention to detail, analytical thinking, and query resolution abilities
Key Responsibilities
- Enter and track ICSRs in PVG systems per SOPs
- Triage, evaluate, and process ICSRs for completeness and reportability
- Code events using MedDRA and prepare accurate narratives
- Identify duplicates, resolve inconsistencies, and perform quality reviews
- Support expedited safety report preparation and submission
- Handle xEVMPD records, SPOR/IDMP activities, and manual recoding
- Conduct literature screening and maintain compliance documentation
- Participate in audits, inspections, and stakeholder collaboration
Benefits/Perks
- Career development with progression, training, and peer recognition
- Supportive Total Self culture promoting authenticity and well-being
- Engaging line management and technical/therapeutic area training
- Total rewards program in a diverse, inclusive global environment
- Opportunity to work on high-impact projects with industry-leading clients
- Stability in a growing CRO focused on innovation and patient outcomes
How to Apply
Apply directly through the official Syneos Health careers portal. Visit Syneos Health Careers and search for Job ID: 25105574 or “Safety & PV Specialist I – Medical Device & PQC” in Gurugram. Submit your resume and join the Talent Network for updates. Act quickly—pharmacovigilance roles fill fast!
Verified Post
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Syneos Health Career Page.
For more pharma jobs, pharmacovigilance opportunities, QA/QC, regulatory affairs, and clinical research positions in India, check .
Why You Should Join
Syneos Health offers a dynamic, inclusive workplace where your contributions matter in advancing life-changing therapies. Benefit from global exposure, continuous learning in pharmacovigilance, strong regulatory focus, and long-term career stability.
With leadership in drug safety operations and a commitment to employee growth, it’s an excellent platform for building expertise in pharmaceutical careers in India, medical device vigilance, and PQC management.
