Safety & PV Submission Specialist I
Syneos Health is hiring Safety & PV Submission Specialist I for its hybrid offices in Gurugram and Hyderabad. This opportunity is ideal for professionals with Pharmacovigilance, Safety Submissions, Clinical Research, and Regulatory Compliance experience looking to work with a leading global Clinical Research Organization (CRO).
Candidates with qualifications in Pharmacy, Life Sciences, Nursing, or equivalent disciplines and at least two years of Pharmacovigilance experience are encouraged to apply.
📋 Job Overview
| Particular | Details |
|---|---|
| Company | Syneos Health |
| Position | Safety & PV Submission Specialist I |
| Department | Pharmacovigilance / Clinical Safety |
| Location | Gurugram & Hyderabad, India |
| Employment Type | Full-Time |
| Work Mode | Hybrid |
| Qualification | Degree in Life Sciences, Pharmacy (B.Pharm/M.Pharm/Pharm.D), Nursing or Equivalent |
| Experience | Minimum 2 Years |
💼 Key Responsibilities
- 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 documentation according to SOPs and project requirements.
🎓 Eligibility Criteria
- B.Pharm
- M.Pharm
- Pharm.D
- Life Sciences Degree
- Nursing
- Equivalent qualification
- Minimum 2 years of Pharmacovigilance experience.
- Experience in a Clinical Research Organization (preferred).
🧠 Required Skills
- Pharmacovigilance
- Safety Submissions
- Regulatory Authority Submissions
- Ethics Committee Submissions
- Trial Master File (TMF)
- Safety Databases
- ICH GCP
- Good Pharmacovigilance Practices (GVP)
- FDA & EMA Guidelines
- Medical Terminology
- Microsoft Office & Outlook
- Communication & Team Collaboration
This role offers the opportunity to work on global clinical research projects, manage regulatory safety submissions, support pharmacovigilance compliance, and collaborate with international sponsors in a hybrid work environment.
💰 Salary & Benefits
Based on similar Safety & Pharmacovigilance Submission Specialist roles in India:
Estimated Salary: ₹7.0 – ₹11.0 LPA
Actual compensation may vary depending on experience, skills, and company policies.
Employee Benefits
- Hybrid Work Model.
- Global Clinical Research Exposure.
- Career Development Programs.
- Technical Training & Learning Opportunities.
- Inclusive Workplace Culture.
- International Project Exposure.
- Employee Recognition Programs.
- Competitive Compensation & Benefits.
🌟 Why Join Syneos Health?
- Work with a leading global Clinical Research Organization (CRO).
- Gain exposure to global Pharmacovigilance and Clinical Safety projects.
- Build expertise in Regulatory Safety Submissions.
- Collaborate with international sponsors and project teams.
- Continuous professional learning and career growth.
- Hybrid working environment with global opportunities.
📈 Career Growth Opportunities
- Senior Safety & PV Submission Specialist
- Drug Safety Associate
- Clinical Safety Associate
- Pharmacovigilance Specialist
- Regulatory Affairs Associate
- Safety Scientist
- PV Team Lead
- Clinical Safety Manager
📑 Resume Tips
- Highlight Pharmacovigilance and Safety Submission experience.
- Mention ICH GCP, GVP, FDA, EMA, and Indian PV guideline knowledge.
- Include TMF and Safety Database experience.
- Showcase SOP documentation and regulatory compliance activities.
- Mention audit or inspection support experience.
- Use an ATS-friendly resume format.
🎯 Interview Questions
- What is Pharmacovigilance?
- What are expedited and periodic safety reports?
- What is the role of a Safety Reporting Plan?
- Explain ICH GCP and GVP.
- What is Trial Master File (TMF)?
- How do you manage regulatory submission timelines?
- What are FDA and EMA safety reporting requirements?
- Why do you want to join Syneos Health?
- Tell us about your Pharmacovigilance experience.
- How do you prioritize multiple submissions?
📌 How to Apply?
Interested and eligible candidates can apply online through the official Syneos Health Careers portal.
🚀 Apply Now
Apply on Syneos Health Careers📚 Related Resources from Medical Jobs India
❓ Frequently Asked Questions
Q. Who can apply?
Candidates with a degree in Life Sciences, Pharmacy (B.Pharm/M.Pharm/Pharm.D), Nursing, or an equivalent qualification and at least 2 years of Pharmacovigilance experience can apply.
Q. What is the work mode?
Hybrid.
Q. Where is the job location?
Gurugram and Hyderabad, India.
Q. What is the estimated salary?
₹7.0–₹11.0 LPA (Estimated).
Q. What are the major responsibilities?
Safety submissions, Regulatory Authority submissions, TMF documentation, Safety Reporting Plans, Pharmacovigilance compliance, and Regulatory documentation.
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