Safety & PV Specialist II (Gurugram / Pune)
Updated: March 13, 2025
Location: India-Asia Pacific - IND-Gurugram-DLF Downtown
Job ID: 25002009
Description
Safety & Pharmacovigilance Specialist II
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. Our Clinical Development model places both the customer and patient at the core of our processes. Through a combination of clinical, medical affairs, and commercial insights, we simplify and streamline operations, making Syneos Health an ideal workplace and partner.
Why Syneos Health?
We emphasize career development and progression.
Supportive management and technical training.
Recognition programs and total rewards initiatives.
A Total Self culture that encourages authenticity and inclusion.
Job Responsibilities:
Enter information into PVG quality and tracking systems for ICSR management.
Assist in project plan development (e.g., Safety Management Plan).
Perform set-up, delivery, and close-out of safety and pharmacovigilance projects.
Process ICSRs per SOPs and project-specific safety plans.
Triage ICSRs, assess completeness, and ensure regulatory compliance.
Enter safety data and code medical events, history, medications, and tests.
Compile narrative summaries and query follow-ups until resolution.
Generate consistent, accurate reports on expedited cases per regulations.
Coordinate with data management teams for safety data reconciliation.
Maintain safety tracking for assigned activities.
Conduct literature reviews, drug coding, and maintain MedDRA dictionary.
Validate and submit xEVMPD product records with appropriate coding.
Handle manual recoding of un-recoded product and substance terms.
Identify and manage duplicate ICSRs.
Perform SPOR/IDMP-related activities.
Conduct quality review of ICSRs and peer-reviewed work.
Serve as subject matter expert in SPVG, providing guidance and training.
Ensure timely distribution of expedited and periodic reports.
Participate in audits/inspections as required.
Submit relevant documents to TMF for clinical trials and PSMF for post-marketing programs.
Maintain compliance with SOPs, WIs, regulations, GCP, ICH, GVP, and project plans.
Qualifications:
Education: Bachelor's Degree in Life Sciences, Pharmacy, Nursing, or related fields (e.g., B. Pharm, M. Pharm, BDM, BMS, BDS).
Experience: 3-5 years of relevant experience in Safety/Pharmacovigilance (ICSR Case Processing).
Proficiency with Safety Database Systems (ARGUS) and medical terminology.
Strong understanding of clinical trial processes across Phases II-IV and post-marketing safety requirements.
Knowledge of ICH GCP, GVP, and applicable regulations.
Proficiency in Microsoft Office Suite and TeamShare or similar content management systems.
Ability to work independently and collaboratively.
Excellent communication, interpersonal, and organizational skills.
Detail-oriented with the ability to prioritize tasks and meet deadlines.
Minimal travel may be required (up to 5%).
Get to Know Syneos Health
Worked on 94% of all Novel FDA Approved Drugs over the past 5 years.
Collaborated on 95% of EMA Authorized Products and 200+ studies across 73,000 sites.
Note: The tasks and responsibilities listed above are not exhaustive. Syneos Health reserves the right to assign additional duties as needed. Qualifications and requirements may vary based on company discretion.
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