Syneos Health has announced a new recruitment opportunity for the position of Safety & PV Specialist II. The company is inviting applications from experienced Pharmacovigilance (PV) professionals with 4–7 years of experience in Individual Case Safety Report (ICSR) processing, safety database management, MedDRA coding, regulatory reporting, and global drug safety operations.
This is a full-time office-based role available at Hyderabad and Gurugram, offering professionals the opportunity to work on global pharmacovigilance projects within a leading Clinical Research Organization (CRO).
Syneos Health Recruitment 2026 – Overview
| Particulars | Details |
|---|---|
| Company Name | Syneos Health |
| Job Role | Safety & PV Specialist II |
| Department | Pharmacovigilance (Drug Safety) |
| Job Location | Hyderabad, Telangana / Gurugram, Haryana |
| Work Mode | Office-Based |
| Employment Type | Full-Time |
| Qualification | B.Pharm, M.Pharm, BDS, BMS, or MBBS |
| Experience | 4–7 Years |
| Application Mode | Online |
Job Responsibilities
The selected candidate will be responsible for:
- Process Individual Case Safety Reports (ICSRs) according to company SOPs and project-specific safety plans.
- Enter and maintain pharmacovigilance data in safety databases and quality tracking systems.
- Perform case triage and evaluate ICSR data for completeness, accuracy, and regulatory reportability.
- Code adverse events, medical history, concomitant medications, laboratory tests, and indications using MedDRA and appropriate coding dictionaries.
- Prepare comprehensive case narratives for safety reports.
- Follow up on missing information and resolve safety queries within defined timelines.
- Support timely submission of expedited safety reports to regulatory authorities.
- Maintain safety tracking records for assigned projects.
- Perform literature screening and review for pharmacovigilance activities.
- Validate and submit xEVMPD product records and perform indication coding using MedDRA.
- Conduct manual recoding of product and substance terms where required.
- Identify and manage duplicate ICSR cases.
- Support SPOR and IDMP-related pharmacovigilance activities.
- Perform quality review of ICSRs to ensure compliance with regulatory requirements.
- Maintain Trial Master File (TMF) documentation and Pharmacovigilance System Master File (PSMF) records.
- Ensure compliance with SOPs, Work Instructions (WIs), ICH-GCP, GVP guidelines, and global pharmacovigilance regulations.
- Participate in internal and external audits as required.
- Collaborate with cross-functional teams to support global safety reporting activities.
Educational Qualification
Candidates should possess one of the following qualifications:
- B.Pharm
- M.Pharm
- BDS
- BMS
- MBBS
Note: Candidates with B.Sc. or M.Sc. qualifications are not eligible for this position as per the company’s requirements.
Experience Required
Applicants should have:
- 4 to 7 years of Pharmacovigilance experience
- Strong expertise in ICSR case processing and global drug safety operations.
- Immediate joiners will be given preference.
Required Skills
The ideal candidate should have experience in:
- Pharmacovigilance (PV)
- Drug Safety
- Individual Case Safety Report (ICSR) Processing
- Safety Database Management
- MedDRA Coding
- Drug Coding
- Case Narrative Writing
- Case Triage
- Literature Screening
- Regulatory Reporting
- xEVMPD Submission
- SPOR
- IDMP
- Duplicate Case Management
- Trial Master File (TMF)
- Pharmacovigilance System Master File (PSMF)
- Good Pharmacovigilance Practices (GVP)
- ICH-GCP Guidelines
- Regulatory Compliance
- Quality Review
- Audit Readiness
Salary Details
Syneos Health has not officially disclosed the salary for this position.
Based on current industry standards, professionals with 4–7 years of Pharmacovigilance experience may expect an estimated annual salary ranging from ₹8 LPA to ₹14 LPA, depending on qualifications, technical expertise, and interview performance.
Employees may also receive:
- Competitive salary package
- Performance-based incentives
- Health and wellness benefits
- Learning and development programs
- Global pharmacovigilance project exposure
- Career growth opportunities
- Employee benefits as per company policy
Job Locations
Selected candidates may be posted at either of the following office locations:
- Hyderabad, Telangana
- Gurugram, Haryana
Work Mode: Office-Based
How to Apply
Interested and eligible candidates can apply online through Syneos Health’s official careers portal.
Before submitting the application, candidates should ensure their resume highlights:
- Pharmacovigilance experience
- ICSR case processing expertise
- MedDRA coding knowledge
- xEVMPD, SPOR, and IDMP experience
- Safety database proficiency
- Regulatory compliance and audit experience
Why Join Syneos Health?
Syneos Health is one of the world’s leading Clinical Research Organizations (CROs), supporting pharmaceutical and biotechnology companies across global clinical development and drug safety programs. Employees benefit from international project exposure, structured learning programs, career progression opportunities, and the chance to work with advanced pharmacovigilance systems in a collaborative environment.
Frequently Asked Questions (FAQs)
What is the job role offered by Syneos Health?
Syneos Health is hiring for the position of Safety & PV Specialist II.
What qualifications are required?
Candidates should have B.Pharm, M.Pharm, BDS, BMS, or MBBS qualifications. B.Sc. and M.Sc. candidates are not eligible for this role.
How much experience is required?
Applicants should have 4 to 7 years of Pharmacovigilance experience.
What are the job locations?
The vacancies are available in Hyderabad and Gurugram.
What are the key responsibilities?
The role involves ICSR case processing, MedDRA coding, safety database management, literature screening, xEVMPD submissions, quality review, regulatory reporting, TMF documentation, and compliance with global pharmacovigilance regulations.
