Location: Gurugram, India (Office-Based)
Company: Syneos Health
Job ID: 25107344
Employment Type: Full-Time
Shift: Night Shift
About the Company
Syneos Health is a leading, fully integrated life sciences organization that accelerates drug development and commercialization for global pharmaceutical and biotechnology companies. With a strong presence across clinical research, medical affairs, and pharmacovigilance, the organization supports innovation at every stage of the product lifecycle.
Job Overview
The Safety & Pharmacovigilance Specialist II is responsible for end-to-end case processing, medical data review, and regulatory compliance within global pharmacovigilance operations. This role is ideal for professionals with hands-on experience in Individual Case Safety Report (ICSR) handling, safety database management, and expedited reporting.
This is a night shift role, requiring alignment with global safety reporting timelines and international stakeholders.
Key Responsibilities
Perform accurate data entry and tracking of ICSRs within pharmacovigilance systems
Triage, assess, and process adverse event cases in accordance with SOPs and safety management plans
Evaluate case completeness, seriousness, expectedness, and regulatory reportability
Conduct MedDRA coding for adverse events, medical history, and concomitant medications
Prepare high-quality narrative summaries for ICSRs
Generate and follow up on medical queries to ensure complete and accurate case documentation
Support expedited reporting to global regulatory authorities within defined timelines
Perform duplicate detection and case reconciliation activities
Conduct literature screening and safety signal identification activities
Manage xEVMPD submissions and ensure compliance with SPOR/IDMP requirements
Perform quality review and validation of safety cases
Ensure proper documentation in Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Participate in audits, inspections, and internal quality checks
Maintain compliance with global regulations including ICH-GCP, GVP, and company SOPs
Eligibility Criteria
Educational Qualification:
B.Pharm, M.Pharm, BDS, BMS, or MBBS
Candidates with BSc/MSc are not eligible for this role
Experience Required
Safety & PV Specialist I: Minimum 2.5–3 years of pharmacovigilance experience
Safety & PV Specialist II: Minimum 4+ years of relevant experience
Freshers are not eligible for this position
Preferred Candidate Profile
Strong expertise in ICSR processing and safety database systems (Argus, ArisG, etc.)
In-depth knowledge of global pharmacovigilance regulations and reporting requirements
Experience with MedDRA coding and drug dictionaries
Familiarity with xEVMPD, SPOR, and IDMP standards
Excellent attention to detail and data quality focus
Ability to work in night shift and handle global timelines
Why Apply for This Role
Work with a globally recognized CRO contributing to high-impact drug safety programs
Gain exposure to international pharmacovigilance standards and regulatory frameworks
Opportunity to work on large-scale clinical and post-marketing safety projects
Structured career progression within drug safety and risk management domain
Important Note for Job Seekers
This is a mid-level pharmacovigilance role requiring prior hands-on experience in safety case processing. Freshers aiming to enter pharmacovigilance are advised to start with entry-level roles such as Drug Safety Associate or PV Trainee positions.
How to Apply
Apply directly through the official careers page of Syneos Health or explore verified global pharmacovigilance opportunities on ThePharmaDaily.com
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Montreal |Brussels :
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Warsaw |
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