Company: Syneos Health
Job Role: Senior Safety & Pharmacovigilance Specialist
Job Type: Full-Time
Work Mode: Office-Based
Job Locations: Hyderabad | Gurugram | Pune
Shift: Night Shift
Experience Required: Minimum 6 Years in Pharmacovigilance
Eligibility: Experienced Candidates Only (Freshers Not Eligible)
Job ID: 25107397
About the Company
Syneos Health is a globally recognized biopharmaceutical solutions organization delivering integrated clinical, medical, and commercial services across the healthcare and life sciences industry. The company partners with pharmaceutical, biotechnology, and medical device innovators to accelerate drug development and improve patient outcomes worldwide.
With a strong global presence and expertise across clinical development and post-marketing safety operations, Syneos Health continues to be one of the leading employers in the pharmacovigilance and clinical research industry.
Job Overview
Syneos Health is hiring experienced Pharmacovigilance professionals for the role of Sr. Safety & PV Specialist for its India offices located in Hyderabad, Gurugram, and Pune. This opportunity is ideal for professionals with strong expertise in ICSR case processing, quality review, MedDRA coding, safety database management, and pharmacovigilance compliance activities.
Candidates applying for this role must be comfortable working in night shifts and should possess hands-on experience in global safety operations.
Key Responsibilities
ICSR Case Processing & Safety Operations
Process Individual Case Safety Reports (ICSRs) as per global SOPs and project-specific safety plans
Perform ICSR triage, case evaluation, regulatory assessment, and data validation
Enter and manage safety data in pharmacovigilance databases
Identify duplicate ICSRs and ensure accurate case reconciliation
Prepare medically accurate narrative summaries for adverse event cases
Coding & Regulatory Compliance
Perform MedDRA coding for adverse events, indications, medical history, and laboratory tests
Handle drug coding and maintenance of safety dictionaries
Support xEVMPD product record validation and submissions
Participate in SPOR/IDMP-related pharmacovigilance activities
Quality Review & Safety Reporting
Conduct Quality Check (QC) and quality review of ICSRs
Ensure timely expedited reporting as per global regulatory timelines
Track safety activities and maintain compliance documentation
Support Trial Master File (TMF) and Pharmacovigilance System Master File documentation
Cross-Functional Collaboration
Collaborate with internal safety teams, sponsors, and global stakeholders
Participate in audits, inspections, and regulatory review activities
Maintain compliance with GCP, ICH Guidelines, GVP, and global pharmacovigilance regulations
Required Qualifications
Educational Qualification
Candidates must possess any one of the following qualifications:
B.Pharm
M.Pharm
BDS
BMS
MBBS
Candidates with BSc or MSc qualifications are not eligible for this role.
Required Skills
Strong experience in ICSR Case Processing
Mandatory experience in Quality Check (QC) / Quality Review
Knowledge of MedDRA coding and safety databases
Understanding of global pharmacovigilance regulations and reporting requirements
Experience with xEVMPD, SPOR, and IDMP activities preferred
Excellent attention to detail and regulatory compliance skills
Experience Requirement
Minimum 6 years of Pharmacovigilance experience is mandatory
Candidates with prior experience in global PV operations and safety review activities will be preferred
Immediate joiners or early joiners will receive preference during shortlisting
Work Location & Shift Details
This is an office-based pharmacovigilance role available at:
Hyderabad
Gurugram
Pune
Applicants must be comfortable working in night shifts as part of global safety operations support.
Why Join Syneos Health?
Opportunity to work with one of the world’s leading CRO organizations
Exposure to global pharmacovigilance and drug safety projects
Collaborative international work environment
Strong career growth opportunities in safety operations and regulatory compliance
Involvement in innovative clinical development programs and post-marketing surveillance activities
Important Note for Applicants
This position is designed for experienced pharmacovigilance professionals only. Freshers and candidates without hands-on ICSR processing and QC experience may not qualify for this role.
Professionals seeking advanced career opportunities in Drug Safety, Pharmacovigilance Operations, Medical Review, Regulatory Compliance, and Global Safety Reporting are strongly encouraged to apply.
About ThePharmaDaily
For more verified global pharmacovigilance jobs, clinical research openings, medical writing careers, regulatory affairs opportunities, and pharma industry updates, visit ThePharmaDaily.com.
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