Are you looking for the latest Safety & PV Submission Specialist jobs in India? Syneos Health is hiring a Safety & PV Submission Specialist I for its Hybrid offices in Gurugram and Hyderabad. This is an excellent opportunity for professionals with experience in Pharmacovigilance (PV), Safety Submissions, Clinical Research, and Regulatory Compliance to work with one of the world’s leading clinical research organizations.
Candidates with a Life Sciences degree, Pharmacy qualification, or Nursing background and at least 2 years of Pharmacovigilance experience are encouraged to apply.
Job Overview
| Job Details | Information |
|---|---|
| Company | Syneos Health |
| Job Title | Safety & PV Submission Specialist I |
| Job Type | Full-Time |
| Work Mode | Hybrid |
| Location | Gurugram & Hyderabad, India |
| Experience | Minimum 2 Years |
| Qualification | Bachelor’s Degree in Life Sciences, Pharmacy, Nursing or Equivalent |
| Department | Pharmacovigilance / Clinical Safety |
| Industry | Clinical Research Organization (CRO) |
About Syneos Health
Syneos Health is a globally recognized Clinical Research Organization (CRO) that supports pharmaceutical, biotechnology, and medical device companies throughout the drug development lifecycle.
The company has contributed to:
- 94% of recent FDA-approved novel drugs
- 95% of EMA-authorized medicines
- 200+ global clinical studies
- 73,000+ research sites worldwide
Syneos Health provides excellent career growth, global exposure, and opportunities to work on innovative clinical development projects.
Key Responsibilities
As a Safety & PV Submission Specialist I, you will:
- Prepare expedited and periodic safety reports.
- Coordinate safety submission activities with sponsors and project teams.
- Develop Safety Reporting Plans.
- Maintain safety submission trackers and documentation.
- Submit safety reports to Regulatory Authorities, Ethics Committees, and Clinical Sites.
- Support Trial Master File (TMF) documentation.
- Ensure compliance with ICH GCP, GVP, FDA, EMA, and Indian Pharmacovigilance guidelines.
- Monitor project timelines and submission metrics.
- Participate in audits and quality inspections.
- Act as the primary contact for safety submission regulatory issues.
- Maintain accurate documentation according to SOPs and project requirements.
Eligibility Criteria
Applicants should possess:
- Bachelor’s Degree in:
- Life Sciences
- Pharmacy (B.Pharm/M.Pharm/Pharm.D)
- Nursing
- Or equivalent qualification
Experience Required
Candidates should have:
- Minimum 2 years of Pharmacovigilance experience
- Experience in Clinical Research Organizations (preferred)
- Hands-on experience with:
- Safety Submissions
- Regulatory Authority submissions
- Ethics Committee submissions
- Trial Master File (TMF)
- Safety databases
Required Skills
Successful candidates should have knowledge of:
- Pharmacovigilance regulations
- FDA Guidelines
- EMA Guidelines
- India PV Guidelines
- ICH GCP
- Good Pharmacovigilance Practices (GVP)
- Clinical Trial Phases II-IV
- Medical Terminology
- Microsoft Office
- Outlook
- Team collaboration tools
Soft skills include:
- Strong communication
- Attention to detail
- Time management
- Problem-solving
- Ability to work independently
- Team collaboration
Why Join Syneos Health?
Employees enjoy:
- Hybrid work model
- Global clinical research exposure
- Career development programs
- Technical training
- Inclusive workplace culture
- International project opportunities
- Employee recognition programs
- Competitive compensation
- Collaborative work environment
Salary (Estimated)
Based on similar Safety & PV Submission Specialist roles in India, the expected salary range is:
โน7,00,000 โ โน11,00,000 per annum (CTC)
Actual salary may vary depending on experience, skills, and interview performance.
Job Location
- Gurugram
- Hyderabad
(Hybrid Work Model)
How to Apply
