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Safety & Pv Specialist Ii (Gurugram / Pune)

3-5 years
Not Disclosed
10 March 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B. Pharm/M. Pharm/ BDM/ BMS/ BDS/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.