Safety & PV Specialist I (Gurugram - Night Shift)
Are you seeking high-paying Pharmacovigilance Specialist Jobs in Gurugram or Drug Safety Specialist Jobs in Gurgaon? Syneos Health®, a leading global biopharmaceutical services organization, is currently hiring experienced professionals for the position of Safety & PV Specialist I for its facility in Gurgaon, Haryana. This office-based role operates in the night shift and is ideal for pharmacy and medical professionals.
As a Safety & PV Specialist, you will manage individual case safety reports (ICSRs), conduct clinical coding, and coordinate safety tracking. If you are preparing for this transition, you can verify your domain readiness by testing yourself with our Entry Level Pharmacovigilance Quiz or studying our list of Top 100 Pharmacovigilance Interview Questions.
📋 Job Details
| Particulars | Details |
|---|---|
| Position | Safety & PV Specialist I |
| Company | Syneos Health |
| Job ID | 25107948 |
| Location | Gurugram, Haryana, India (Office-Based) |
| Employment Type | Full-Time |
| Shift Timing | Night Shift (Mandatory) |
| Experience Required | Minimum 2.6 Years in Safety / PV |
| Educational Background | B.Pharm / M.Pharm / BDS / BHMS / BAMS / MBBS (No B.Sc / M.Sc) |
💼 Key Responsibilities
- Enter relevant data into pharmacovigilance (PVG) quality databases for tracking and listing ICSRs.
- Process Individual Case Safety Reports (ICSRs) per Standard Operating Procedures (SOPs) and study safety plans.
- Triage safety reports, evaluating incoming case data for completeness, accuracy, and regulatory reporting rules.
- Perform data entry into safety databases and code clinical events using standard drug dictionaries.
- Conduct medical coding (MedDRA coding) of medical history, adverse events, and concomitant medications.
- Compile accurate and complete clinical narrative summaries for safety reporting.
- Identify missing case data, draft clarification queries, and follow up with sites until resolution.
- Support expedited safety reporting to regulatory authorities in compliance with timeline guidelines.
- Conduct literature screening, review databases for safety signals, and manage product dictionary files.
- Handle xEVMPD product record submission, validation, and manual recoding of terms.
- Triage Trial Master File (TMF) documentation to ensure full compliance with audit guidelines.
Safety processing is a highly detailed, compliance-driven field. If you are comparing your options in data and drug development, read our analysis on Drug Safety Analyst Roles to understand safety database architectures.
🎓 Qualifications & Requirements
- Must hold a degree in B.Pharm, M.Pharm, BDS, BHMS, BAMS, or MBBS (Please note: B.Sc and M.Sc graduates are NOT eligible for this role).
- Minimum of 2.6 years of active experience in Pharmacovigilance safety processing and case handling.
- Proficiency with MedDRA coding, safety database systems (Argus, ArisG), and ICSR processing.
- Comfortable working full-time from the Gurugram office during night shifts.
- Strong communication, analytical thinking, and documentation skills.
- Immediate or early joiners will be given priority in the screening process.
For pharmacy graduates, regulatory and safety fields offer robust international growth. Read more about pathways in our article on B.Pharm Careers: India vs USA.
💰 Salary & Benefits
Syneos Health offers a highly competitive salary package matching the experience level of candidates, alongside:
- Lucrative base pay with night shift allowances.
- Accidental and medical insurance coverage for employees.
- Supportive line management and therapeutic area training modules.
- Robust peer recognition programs and career progression pathways.
Safety professionals earn premium packages as they gain seniority. You can compare earnings potential in our comparison of Pharmacovigilance Salary: India vs USA.
🌟 Why Join Syneos Health?
- Work with a leading global biopharmaceutical service organization partner.
- Be part of a collaborative, high-energy team of passionate problem solvers.
- Clear corporate training models for technical and professional growth.
- A culture that encourages authenticity, inclusion, and diversity.
📑 Resume Tips
- Highlight your case processing volume and average turnaround times.
- Detail your experience with safety tools (Argus/ArisG) and MedDRA/WHO-DD coding.
- Explicitly mention your willingness to work night shifts at the Gurugram office.
- Ensure your CV is clean, ATS-compliant, and lists your key qualifications.
🎯 Interview Questions
- What are the essential elements required to constitute a valid ICSR case?
- How do you prioritize case processing based on seriousness and regulatory timelines?
- Explain your experience with MedDRA coding for adverse events and medical history.
- What is xEVMPD, and why is product record validation important in safety operations?
- How do you handle incomplete clinical case information when triaging reports?
📌 How to Apply?
Interested candidates who fulfill the eligibility criteria can apply online by visiting the official Syneos Health Workday application portal. To prepare your profile and optimize your applications for corporate databases, read our guide on how to apply for healthcare and pharma jobs online.
🚀 Apply Now
Apply Online❓ Frequently Asked Questions
Q. Are B.Sc or M.Sc graduates eligible?
No. The company has explicitly stated that only B.Pharm, M.Pharm, BDS, BHMS, BAMS, or MBBS candidates are eligible for this role.
Q. Is this a work from home job?
No, this is a full-time, office-based role located at the Gurugram office.
Q. What is the shift timing?
This role requires working night shifts to coordinate with international pharmacovigilance teams.
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