Leading global CRO Syneos Health has announced openings for the position of Safety & PV Specialist I at its Gurugram and Hyderabad offices. This is an excellent opportunity for experienced pharmacovigilance professionals looking to advance their careers in drug safety, case processing, and regulatory compliance within a globally recognized healthcare organization.
Candidates with a background in Pharmacy, Dentistry, Medical Sciences, and related healthcare disciplines along with pharmacovigilance experience are encouraged to apply.
Job Overview
| Particulars | Details |
|---|---|
| Job Title | Safety & PV Specialist I |
| Company | Syneos Health |
| Location | Gurugram, Haryana / Hyderabad, Telangana |
| Job Type | Full-Time |
| Work Mode | Office-Based |
| Shift | Night Shift |
| Experience | Minimum 2.6 Years |
| Qualification | B.Pharm, M.Pharm, BDS, BMS, MBBS |
| Application Status | Open |
About Syneos Health
Syneos Health is a global biopharmaceutical solutions organization that helps pharmaceutical, biotechnology, and medical device companies accelerate clinical development and commercialization. The company partners with innovators worldwide to bring life-changing therapies to patients faster.
With more than 25,000 professionals globally, Syneos Health has contributed to the development of a significant percentage of FDA-approved and EMA-authorized therapies over recent years.
Key Responsibilities
The selected Safety & PV Specialist I will be responsible for:
- Processing Individual Case Safety Reports (ICSRs) according to SOPs and regulatory requirements.
- Entering and maintaining safety data in pharmacovigilance databases.
- Reviewing and triaging adverse event reports.
- Evaluating case data for completeness, accuracy, and reportability.
- Performing MedDRA coding and drug coding activities.
- Preparing comprehensive case narratives.
- Conducting follow-up activities to obtain missing safety information.
- Supporting expedited safety reporting submissions.
- Managing duplicate ICSR identification and reconciliation.
- Performing literature screening and safety surveillance activities.
- Supporting xEVMPD validation and product record submissions.
- Assisting with SPOR and IDMP-related pharmacovigilance activities.
- Conducting quality reviews of safety cases.
- Maintaining compliance with GVP, ICH, GCP, and company procedures.
- Supporting inspections, audits, and regulatory activities.
Eligibility Criteria
Educational Qualification
Applicants must possess any of the following qualifications:
- B.Pharm
- M.Pharm
- BDS
- BMS
- MBBS
Note: B.Sc and M.Sc candidates are not eligible for this position.
Experience Required
- Minimum 2.6 years of Pharmacovigilance experience
- Experience in ICSR processing, case management, safety databases, MedDRA coding, and regulatory reporting preferred.
- Immediate joiners and early joiners will be given preference.
Shift Requirement
Candidates must be comfortable working in night shifts.
Preferred Skills
- Pharmacovigilance case processing
- Adverse event reporting
- ICSR lifecycle management
- MedDRA coding
- Drug safety databases
- Regulatory compliance
- Signal detection support
- Literature review
- Quality review of safety cases
- Strong communication and documentation skills
Why Join Syneos Health?
Employees at Syneos Health benefit from:
- Global exposure in clinical research and pharmacovigilance
- Career growth and progression opportunities
- Continuous learning and development programs
- Therapeutic and technical training
- Inclusive and collaborative work culture
- Recognition and rewards programs
- Opportunity to work with leading pharmaceutical and biotech companies worldwide
How to Apply
