Safety & Pharmacovigilance (PV) Specialist I
Location: Gurugram / Pune, India
Job ID: 25103034
Updated: November 11, 2025
Employment Type: Full-Time
About the Company
Syneos Health® is a fully integrated global biopharmaceutical solutions organization focused on accelerating clinical development and commercial success. With a presence in over 110 countries and a workforce of 29,000 professionals, the company delivers comprehensive clinical, medical affairs and commercial execution services. Syneos Health continuously drives innovation, operational excellence and patient-centered delivery.
Position Overview
The Safety & PV Specialist I is responsible for supporting global pharmacovigilance operations through high-quality ICSR case processing, data entry, safety database management, literature screening and regulatory reporting activities. This role ensures compliance with global PV regulations, company SOPs and project-specific safety plans.
The position requires 2.5–4 years of experience in Pharmacovigilance, particularly in ICSR processing, safety databases such as Argus and ArisG, MedDRA coding and PV quality systems.
Key Responsibilities
ICSR Case Processing
Perform data entry, booking and triage of Individual Case Safety Reports.
Review ICSRs for completeness, accuracy and regulatory reportability.
Enter and update safety information in the safety database.
Code events, medical history, lab tests, concomitant medications and relevant terms.
Prepare comprehensive narrative summaries.
Identify, query, and follow up on missing or inconsistent information.
Conduct quality review and duplicate management of ICSRs.
Support timely preparation and submission of regulatory expedited reports.
Safety Database & PV Systems
Maintain entries in PV tracking systems for ICSR receipt and workflow updates.
Work with Argus and ArisG databases for case processing and reporting.
Perform xEVMPD product record validation and submission.
Manage drug coding and dictionary maintenance activities.
Execute manual recoding of product and substance terms arising from ICSRs.
Literature & Safety Intelligence
Conduct literature screening and review for safety data.
Apply MedDRA coding and ensure standardized terminology usage.
Contribute to SPOR/IDMP-related activities.
Utilize regulatory safety intelligence and apply it to daily reporting activities.
Documentation & Compliance
Ensure accurate document submission to the Trial Master File (TMF) and Pharmacovigilance System Master File.
Adhere to company SOPs, Work Instructions, GVP, ICH guidelines and global PV regulations.
Maintain compliance with project plans and reporting timelines.
Participate in internal and external audits as required.
Cross-Functional Collaboration
Build strong professional relationships with internal teams and stakeholders.
Contribute to a collaborative, high-performance work environment.
Support continuous improvement of PV operations.
Qualifications and Experience
Education
B. Pharm, M. Pharm, BDS, BMS, MBBS
Note: BSc / MSc candidates are not eligible for this role.
Experience
2.5–4 years of experience in Pharmacovigilance.
Mandatory: ICSR case processing experience.
Hands-on experience with Argus and/or ArisG safety databases.
Technical Skills
Strong knowledge of medical terminology and MedDRA coding.
Understanding of global drug safety regulations, GVP and ICH guidelines.
Ability to work with PV quality tracking systems and case processing workflows.
Soft Skills
Strong analytical and problem-solving skills.
Excellent written and verbal communication abilities.
Ability to work under tight timelines and maintain accuracy.
Team-oriented mindset with a focus on collaboration and process improvement.
Why Work at Syneos Health
Structured career development and internal progression opportunities.
Supportive leadership and continuous training programs.
Inclusive global culture encouraging authenticity and diversity.
Competitive rewards and recognition programs.
Syneos Health has contributed to:
94% of FDA-approved novel drugs
95% of EMA-authorized products
200+ studies across 73,000 sites and 675,000+ trial patients
How to Apply
Candidates may apply through the Syneos Health career portal or join the Talent Network to stay updated on future opportunities.
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