Safety Pharmacovigilance Specialist Job at Syneos Health in Gurugram for experienced PV professionals with ICSR processing and PQC case experience.
The pharmacovigilance and drug safety sector continues to grow as pharmaceutical companies strengthen safety monitoring and regulatory compliance systems. Skilled professionals who can manage safety data, process Individual Case Safety Reports, and ensure regulatory reporting accuracy are essential for protecting patient safety and maintaining global healthcare standards.
Syneos Health is currently recruiting experienced pharmacovigilance professionals for the position of Safety & Pharmacovigilance Specialist I in Gurugram, India. This opportunity is ideal for candidates who have hands-on experience in ICSR processing, safety database management, and Product Quality Complaint (PQC) case handling within the pharmaceutical or clinical research industry.
Professionals joining this role will contribute to global drug safety operations and work with international regulatory standards in pharmacovigilance. Safety Pharmacovigilance Specialist Job at Syneos Health
Company Overview
Syneos Health is a global biopharmaceutical solutions organization that provides integrated clinical development, medical affairs, and commercialization services to pharmaceutical, biotechnology, and healthcare companies worldwide.
The organization focuses on accelerating the delivery of innovative therapies to patients by combining scientific expertise, advanced technology, and global clinical research capabilities. With thousands of professionals working across more than 100 countries, the company plays an important role in supporting clinical trials, safety monitoring, and regulatory compliance activities across the global pharmaceutical industry. Safety Pharmacovigilance Specialist Job at Syneos Health
Job Overview
| Job Title | Safety & Pharmacovigilance Specialist I |
|---|---|
| Company | Syneos Health |
| Qualification | B.Pharm, M.Pharm, PharmD, BDS, BMS, MBBS |
| Experience | 2.5 – 4 Years |
| Job Location | Gurugram, India |
| Employment Type | Full-Time |
| Work Mode | Office-Based |
| Department | Pharmacovigilance / Drug Safety |
| Application Mode | Online |
Job Location & Employment Type
Location: Gurugram, Haryana, India
Work Mode: Office-Based
Employment Type: Full-Time
The selected candidate will work within the pharmacovigilance and drug safety department responsible for global safety case processing and regulatory reporting activities. Safety Pharmacovigilance Specialist Job at Syneos Health
Key Roles & Responsibilities
ICSR Processing & Case Management
- Enter safety case information into pharmacovigilance tracking systems
- Process Individual Case Safety Reports according to SOPs and project safety plans
- Evaluate case data for completeness and regulatory reportability
- Enter safety case data into Argus or ARISg safety databases
- Code adverse events, medications, and medical history using MedDRA dictionaries
- Prepare accurate narrative summaries for safety reports
- Identify missing case information and follow up with relevant stakeholders
- Detect and manage duplicate ICSRs
- Perform quality checks and case review before submission
Regulatory Reporting & Compliance
- Support preparation and submission of expedited safety reports
- Validate and submit xEVMPD product records
- Perform recoding of product and substance terms derived from safety cases
- Assist with SPOR and IDMP regulatory data activities
- Maintain safety tracking documentation for assigned projects
- Ensure documents are submitted to Trial Master File (TMF) and PSMF when required
- Apply global pharmacovigilance regulatory intelligence to safety reporting tasks
Literature & Audit Support
- Conduct literature screening and safety reviews
- Maintain drug dictionaries and coding databases
- Ensure compliance with GCP, ICH guidelines, and global pharmacovigilance regulations
- Support internal and external audits
- Collaborate with internal teams and external stakeholders for safety operations
Safety Pharmacovigilance Specialist Job at Syneos Health
Eligibility Criteria
Education
Candidates must have one of the following qualifications:
- B.Pharm
- M.Pharm
- PharmD
- BDS
- BMS
- MBBS
B.Sc or M.Sc candidates are not eligible for this role.
Experience
- 2.5 – 4 years of pharmacovigilance experience
- At least 1 year of experience handling Product Quality Complaint (PQC) cases
Skills Required
- Experience using Argus or ARISg safety databases
- Knowledge of global pharmacovigilance reporting regulations
- Understanding of clinical trial safety monitoring and post-marketing surveillance
- Knowledge of clinical trial phases II–IV safety processes
- Strong attention to detail and data analysis skills
- Proficiency in Microsoft Office tools
Salary & Benefits
Salary for this role will be as per company norms, depending on the candidate’s experience and qualifications.
Employees may also benefit from:
- Career development and technical training programs
- Exposure to global pharmacovigilance systems
- Opportunities to work on international clinical safety programs
- Professional growth within drug safety and regulatory compliance fields
Safety Pharmacovigilance Specialist Job at Syneos Health
Selection Process
The hiring process may include the following stages:
- Resume screening
- Technical interview for pharmacovigilance expertise
- Final interview with hiring managers
- Offer and onboarding process
Candidates with strong experience in ICSR processing, PQC case handling, and safety database management may receive preference. Safety Pharmacovigilance Specialist Job at Syneos Health
How to Apply
Interested candidates can apply through the official career portal of the company.
Applicants should ensure their resume clearly highlights pharmacovigilance experience, safety case processing expertise, and familiarity with Argus or ARISg systems. Safety Pharmacovigilance Specialist Job at Syneos Health
Why Apply for This Pharma Job?
The Safety & Pharmacovigilance Specialist role provides a valuable opportunity for professionals looking to grow in the drug safety and pharmacovigilance domain. The position offers exposure to global pharmacovigilance operations, regulatory reporting systems, and clinical safety monitoring processes.
Professionals working in this role can strengthen their expertise in ICSR processing, safety database management, and regulatory compliance, which are essential skills for long-term career development in the pharmaceutical and clinical research industries. Safety Pharmacovigilance Specialist Job at Syneos Health
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical and healthcare job opportunities for informational purposes only. We are not affiliated with any pharmaceutical company, recruitment agency, or organization mentioned in the job listings. Candidates are advised to verify job details directly with the employer before applying. Safety Pharmacovigilance Specialist Job at Syneos Health
Final Call to Apply
If you have experience in pharmacovigilance case processing and Product Quality Complaint handling, this opportunity can help advance your career in global drug safety operations. Eligible candidates are encouraged to apply through the official company career portal and explore this professional opportunity. Safety Pharmacovigilance Specialist Job at Syneos Health
