Syneos Health Hiring Safety & PV Specialist I | Hyderabad, Gurugram & Pune
Are you searching for Syneos Health Pharmacovigilance Careers or Drug Safety Specialist Jobs India? Leading life sciences CRO Syneos Health is hiring a Safety & PV Specialist I at multiple India locations — Hyderabad, Gurugram, and Pune — to join its Global Pharmacovigilance (PVG) team.
This is an excellent opportunity for candidates with experience in ICSR processing, MedDRA coding, safety database entry, and aggregate safety reporting who want to build a career in global drug safety operations. To write a pharmacovigilance-focused resume, read our complete guide on how to apply for healthcare and pharma jobs online.
📋 Job Details
| Particular | Details |
|---|---|
| Company | Syneos Health |
| Position | Safety & PV Specialist I |
| Job Location | Hyderabad | Gurugram | Pune (Office-Based) |
| Department | Global Pharmacovigilance (PVG) |
| Employment Type | Full-Time |
| Experience Required | Preferred: PV / Drug Safety Experience |
| Estimated Salary | As Per Industry Standards |
| Last Date to Apply | July 3, 2026 |
💼 Key Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking of Individual Case Safety Reports (ICSRs).
- Assist in processing ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.
- Triage ICSRs, evaluating data for completeness, accuracy, and regulatory reportability.
- Enter adverse event data into the safety database and perform MedDRA coding of events, medical history, and concomitant medications.
- Compile complete, accurate narrative summaries for ICSRs.
- Identify information gaps, raise queries, and follow up until resolution.
- Assist in the generation of timely expedited safety reports in compliance with applicable regulatory requirements.
- Perform literature screening and review for safety signal detection and drug coding.
- Manage xEVMPD product record validation, submission, and MedDRA indication coding.
- Perform manual recoding of unrecoded product and substance terms from ICSRs.
- Identify and manage duplicate ICSRs and perform quality review.
- Support SPOR / IDMP-related activities and maintain PSMF documentation.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) as per SOPs.
- Maintain compliance with SOPs, WIs, ICH guidelines, GCP, and GVP modules.
- Participate in regulatory audits and inspections as required.
To compare ICSR processing salaries and career trajectories between India and the US, read our report on Pharmacovigilance Salary: India vs USA.
🎓 Required Qualifications & Skills
- Education: B.Pharm, M.Pharm, Pharm.D, M.Sc Life Sciences, Nursing, or relevant allied healthcare degree.
- Experience: Prior experience in pharmacovigilance, ICSR processing, drug safety, or medical information preferred.
- Technical Skills: Working knowledge of safety databases (Argus, ARISg, or similar), MedDRA coding, WHO Drug Dictionary, and regulatory requirements (ICH E2A/E2B, GVP modules).
- Regulatory Knowledge: Familiarity with FDA, EMA, CDSCO, ICH, and GCP/GVP guidelines for adverse event reporting.
- Soft Skills: Excellent attention to detail, strong analytical skills, ability to manage deadlines, and good written/verbal communication in English.
To compare pharmacovigilance career progression at CROs like Syneos versus pharmaceutical companies, read our guide on B.Pharm Careers after Graduation: India vs USA.
🎁 Why Join Syneos Health?
- Work with one of the world's most respected fully-integrated CROs, having supported 94% of all Novel FDA Approved Drugs in the last 5 years.
- Exposure to global drug safety programs across clinical and post-marketing phases.
- Strong emphasis on career development, learning opportunities, and therapeutic area training.
- Inclusive, collaborative working culture committed to patient impact.
- Multiple India locations available — Hyderabad, Gurugram, and Pune.
To assess your clinical research and regulatory knowledge, try our interactive Clinical Trial Assistant (CTA) Quiz.
💡 Pharmacovigilance vs Healthcare IT
Safety & PV Specialists manage adverse event data, regulatory submissions, and MedDRA coding, while healthcare IT professionals maintain the platforms and infrastructure that support safety systems. To understand these career differences, read our comparison on Healthcare IT vs Clinical Healthcare.
📝 Resume Tips for Syneos Health Safety & PV Specialist
- Highlight Safety Database Experience: Specifically mention proficiency in Argus Safety, ARISg, or other pharmacovigilance databases along with MedDRA and WHO Drug Dictionary coding experience.
- Emphasize Regulatory Knowledge: Showcase familiarity with ICH E2A, E2B(R3), GVP modules, FDA/EMA reporting timelines, and expedited report formats (CIOMS I, MedWatch).
- Quantify Achievements: Where possible, mention the volume of ICSRs processed (e.g., "processed 200+ ICSRs monthly") and any experience with regulatory audits or inspections.
- Mention SOPs and Quality Standards: Highlight experience working under GCP/GVP-compliant SOPs, WIs, and quality-driven processes.
💬 Syneos Health Safety & PV Specialist Interview Questions
- Q1. What is an ICSR and what are the key elements of a valid ICSR?
Answer Guidance: An Individual Case Safety Report (ICSR) documents adverse events. The four minimum criteria for validity are: an identifiable reporter, an identifiable patient, a suspect drug, and an adverse event/reaction. - Q2. What are the regulatory timelines for submitting an expedited safety report?
Answer Guidance: Serious unexpected adverse reactions from clinical trials must be submitted within 7 calendar days (fatal/life-threatening) or 15 calendar days (other serious). Post-marketing serious unexpected reports are typically within 15 days. - Q3. Can you explain the MedDRA hierarchy and how you would select the correct Preferred Term (PT) for an adverse event?
Answer Guidance: MedDRA has five levels — SOC, HLGT, HLT, PT, and LLT. Select the PT that most precisely captures the clinician-reported event, using the verbatim term at LLT as the starting point and working up to find the best-fit PT.
🚀 How to Apply?
Eligible candidates can submit their application directly via Syneos Health's official Workday careers portal. Click the button below:
Apply Online – Syneos Health Careers Portal⏰ Last Date to Apply: July 3, 2026
❓ Frequently Asked Questions
Q. Which cities are covered under this job posting?
This role is open at three India locations: Hyderabad (Telangana), Gurugram (Haryana), and Pune (Maharashtra).
Q. Is this a remote or office-based role?
This is an office-based, full-time position at Syneos Health's India offices.
Q. What is the last date to apply for this Syneos Health safety job?
The last date to apply for the Safety & PV Specialist I position is July 3, 2026. Apply at the earliest.
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