Safety & PV Submission Specialist I
Company: Syneos Health
Location: Gurugram / Hyderabad, India (Hybrid)
Job ID: 25109845
Updated On: July 3, 2026
Job Summary
Syneos Health is hiring a Safety & PV Submission Specialist I to support safety reporting and pharmacovigilance (PV) submission activities for clinical trials and post-marketing programs. The role involves preparing and submitting expedited and periodic safety reports, ensuring compliance with global regulatory requirements, maintaining Trial Master File (TMF) documentation, and collaborating with sponsors and cross-functional teams to ensure timely and accurate safety submissions.
Key Responsibilities
Prepare, assemble, and submit expedited and periodic safety reports.
Collaborate with sponsors and project management teams on safety reporting activities.
Participate in project launch activities for safety submissions.
Prepare and maintain Safety Reporting Plans.
Track safety submissions and maintain submission records.
Provide sponsors with safety submission status updates.
Resolve safety reporting and regulatory submission issues.
Apply global pharmacovigilance regulatory guidelines to submission activities.
File and maintain project documents as per sponsor and company requirements.
Forward completed safety submission documents to sponsors and regulatory authorities.
Act as the point of contact for safety submission-related regulatory issues.
Assist in workload distribution and project coordination when required.
Participate in internal project review meetings.
Monitor project metrics, KPIs, and submission timelines.
Support internal and external audits.
Maintain Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) documentation.
Ensure compliance with SOPs, ICH-GCP, GVP, FDA, EMA, and Indian pharmacovigilance regulations.
Required Skills
Pharmacovigilance (PV)
Safety Reporting
Safety Submissions
Expedited & Periodic Safety Reports
Trial Master File (TMF)
Pharmacovigilance System Master File (PSMF)
Regulatory Submissions
Ethics Committee Submissions
FDA, EMA & India PV Guidelines
ICH-GCP & GVP Compliance
Clinical Trial Safety
Safety Database Systems
Medical Terminology
Microsoft Office (Word, Excel, PowerPoint, Outlook)
Project Coordination
Documentation Management
Communication & Presentation Skills
Time Management
Attention to Detail
Eligibility
Bachelor's Degree in Life Sciences, Pharmacy, Nursing, or an equivalent qualification.
Registered Nurse or Pharmacist candidates are also eligible.
Experience in Clinical Research Organization (CRO) or Pharmacovigilance is preferred.
Knowledge of clinical trial safety reporting and global regulatory requirements.
Strong understanding of clinical trial phases (II–IV) and post-marketing safety activities.
Experience
Required Experience: Minimum 2 years of experience in Pharmacovigilance (PV), Drug Safety, Safety Reporting, or Safety Submissions, preferably within a CRO environment.
Salary Package (Estimated Market Standard)
₹6.5 LPA – ₹10 LPA (depending on experience, pharmacovigilance expertise, and interview performance).
Work Mode
Hybrid
Gurugram or Hyderabad Location
Up to 5% travel may be required
Why Join Syneos Health?
Opportunity to work on global pharmacovigilance and clinical research projects.
Career development and continuous learning programs.
Collaborative and inclusive work culture.
Exposure to international regulatory authorities and safety reporting processes.
Employee recognition and performance rewards.
Opportunity to contribute to global drug safety and patient health initiatives.
About Syneos Health
Syneos Health is a leading global life sciences organization that supports pharmaceutical, biotechnology, and healthcare companies across the drug development and commercialization lifecycle. Over the past five years, the company has contributed to 94% of FDA-approved novel drugs, 95% of EMA-authorized products, and supported 200+ clinical studies across 73,000 sites involving more than 675,000 clinical trial participants.
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