Syneos Health Hiring Senior Safety & PV Submission Specialist
- Syneos Health Hiring Senior Safety & PV Submission Specialist | Pharmacovigilance Leadership Role in India
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities:
- Eligibility / Qualifications
- Educational Qualification:
- Relevant Courses:
- Experience:
- Required Skills
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- Who can apply for this role?
- Is safety submission experience mandatory?
- What is the work model?
- What career growth can I expect?
- What regulatory knowledge is required?
Syneos Health Hiring Senior Safety & PV Submission Specialist | Pharmacovigilance Leadership Role in India
Syneos Health is hiring for the position of Senior Safety & Pharmacovigilance (PV) Submission Specialist for its Gurugram and Hyderabad locations with a hybrid work model. This opportunity is designed for experienced professionals with strong expertise in pharmacovigilance, safety reporting, and regulatory submissions, particularly those with 6+ years of experience in clinical research organizations or pharmaceutical environments.
This is a senior-level role focused on safety submissions, regulatory compliance, and pharmacovigilance operations, offering exposure to global drug development programs and regulatory authorities like the FDA and EMA.
Company Overview
Syneos Health is a leading global life sciences services organization that integrates clinical development, medical affairs, and commercial solutions. The company partners with pharmaceutical, biotechnology, and healthcare organizations to accelerate drug development and commercialization.
With experience supporting over 90% of FDA-approved drugs and a strong global footprint, Syneos Health is known for its innovation-driven approach, regulatory expertise, and commitment to improving patient outcomes. Employees gain exposure to large-scale global clinical trials and advanced pharmacovigilance systems.
Job Role & Responsibilities
As a Senior Safety & PV Submission Specialist, you will lead safety reporting activities, manage regulatory submissions, and ensure compliance with global pharmacovigilance guidelines.
Key Responsibilities:
Safety Submissions & Reporting
- Prepare and manage expedited and periodic safety reports for regulatory authorities
- Develop Safety Reporting Plans for assigned projects
- Track and monitor safety submissions and ensure timely delivery
- Submit safety reports to regulatory authorities, ethics committees, and stakeholders
Regulatory Compliance & PV Operations
- Ensure compliance with global pharmacovigilance regulations including ICH, GCP, GVP, FDA, and EMA guidelines
- Maintain and file documents in Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
- Apply regulatory intelligence to safety reporting processes
Project Management & Leadership
- Collaborate with sponsors and internal teams for safety reporting activities
- Lead or support project teams and manage workload distribution
- Participate in audits, inspections, and project review meetings
- Track KPIs and submission timelines for continuous improvement
Documentation & Communication
- Maintain accurate documentation of safety submissions
- Act as a point of contact for regulatory safety queries
- Communicate updates and submission status to stakeholders
Eligibility / Qualifications
Educational Qualification:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related fields
Relevant Courses:
B.Pharmacy, M.Pharmacy, Pharm.D, BSc Nursing, BSc Life Sciences, MSc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research
Experience:
- Minimum 6 years of experience in pharmacovigilance and safety submissions
- Experience in CRO or pharmaceutical industry preferred
- Strong experience in regulatory submissions to health authorities
Required Skills
- In-depth knowledge of pharmacovigilance and drug safety processes
- Strong understanding of ICH GCP, GVP, FDA, EMA, and global regulations
- Experience with safety databases and medical terminology
- Strong project management and organizational skills
- Excellent communication and stakeholder management abilities
- Proficiency in Microsoft Office tools and collaboration platforms
Location & Salary
- Job Location: Gurugram & Hyderabad (Hybrid)
- Work Type: Full-time
- Salary: High-paying package based on experience and industry standards in pharmacovigilance and regulatory affairs
Application Process
Interested candidates can apply through the official Syneos Health careers portal:
Frequently Asked Questions (FAQs)
Who can apply for this role?
Candidates with Life Sciences, Pharmacy, or Nursing backgrounds and at least 6 years of pharmacovigilance experience can apply.
Is safety submission experience mandatory?
Yes, hands-on experience in safety submissions to regulatory authorities is required.
What is the work model?
The role follows a hybrid work model in Gurugram or Hyderabad.
What career growth can I expect?
You can advance to roles such as PV Manager, Drug Safety Lead, or Regulatory Affairs Specialist.
What regulatory knowledge is required?
Candidates should be familiar with ICH GCP, GVP, FDA, EMA, and global pharmacovigilance guidelines.
| Category | Details |
|---|---|
| Company | Syneos Health |
| Vacancies | Senior Safety & PV Submission Specialist |
| Required Education | Life Sciences / Pharmacy / Nursing |
| Experience | Minimum 6 Years |
To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.
