Looking to grow your career in pharmacovigilance and regulatory safety submissions?
Syneos Health is hiring an experienced Safety & PV Submission Specialist II for its Gurugram and Hyderabad offices (Hybrid work model).
This is an excellent opportunity for professionals with 4+ years of PV experience to work on global safety projects and regulatory submissions.
About Syneos Health
Syneos Health is a globally recognized biopharmaceutical solutions company that supports organizations from clinical development to commercialization.
The company is known for:
- Strong expertise in drug development and safety
- Global presence with innovative solutions
- Employee-focused culture and career growth opportunities
- Commitment to quality, compliance, and patient safety
Job Overview
- Company: Syneos Health
- Role: Safety & PV Submission Specialist II
- Department: Pharmacovigilance / Drug Safety
- Experience: Minimum 4 Years
- Job Location: Gurugram / Hyderabad
- Work Mode: Hybrid
Eligibility Criteria
- Bachelor’s Degree in:
- Life Sciences
- Pharmacy
- Nursing (RN)
- Or equivalent qualification
Skills Required
- Strong experience in safety submissions to regulatory authorities
- Knowledge of EMA, FDA, ICH-GCP, GVP guidelines
- Familiarity with pharmacovigilance systems and databases
- Understanding of medical terminology and regulatory requirements
- Experience in TMF (Trial Master File) management
- Excellent communication and multitasking skills
Key Responsibilities
- Prepare and submit expedited and periodic safety reports
- Track submission timelines and maintain status reports
- Ensure compliance with global PV regulations
- File and manage documents in TMF and PV systems
- Support project initiation and internal review meetings
- Participate in audits and ensure adherence to SOPs
Benefits & Perks
- Competitive salary and benefits package
- Opportunity to work on global pharmacovigilance projects
- Continuous learning and development programs
- Inclusive and collaborative work environment
- Long-term career growth in a reputed CRO
How to Apply
Interested candidates can apply directly through the official Syneos Health careers portal.
Job ID: 25108530
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Syneos Health career page.
Apply now and take the next step in your pharmacovigilance career.
Walk-In Details
- No walk-in interview
- Online application only
Why You Should Join Syneos Health
- Work with a global leader in life sciences
- Exposure to clinical and post-marketing safety projects
- Strong focus on innovation and regulatory excellence
- Career advancement in pharmacovigilance and safety operations
- Meaningful work contributing to patient safety worldwide
FAQs
Q1: What experience is required?
Minimum 4 years of experience in pharmacovigilance, including safety submissions.
Q2: What qualifications are needed?
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent.
Q3: What are the job locations?
Gurugram or Hyderabad with a hybrid work model.
Q4: Is this role related to clinical trials?
Yes, it supports both clinical trial and post-marketing safety reporting.
Q5: How can I apply?
Apply through the official portal using Job ID 25108530.
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