Instagram
youtube
Facebook

Sr. Pv Associate

3-5 years
Not Disclosed
10 Feb. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Senior Pharmacovigilance Associate (Sr. PV Associate)
Experience Required: 3-5 years of relevant experience
Location:
Mohali/Chandigarh
Compensation: 20-25% rise on current CTC

Key Responsibilities:

  • Drug Safety Management Support:

    • Provide technical and process-related support to drug safety management for both clinical trials and post-marketed products.

    • Ensure compliance with relevant regulations and Standard Operating Procedures (SOPs) throughout the pharmacovigilance processes.

  • ICSR Management:

    • Process Individual Case Safety Reports (ICSRs) from various sources including literature search and review.

    • Support signal detection and management, track regulatory information, and perform regulatory submissions.

    • Contribute to the preparation of aggregate safety reports, study reports, and other safety-related documentation.

    • Assist in Medical and Product Dictionary Management activities as required.

  • ICSR Compliance:

    • Ensure ICSR compliance with International and local regulatory reporting requirements.

    • Conduct quality review of ICSRs, generate relevant metrics, and investigate late case reports.

    • Maintain accurate tracking of cases and resolve any compliance-related issues.

Required Skills:

  • Strong experience in pharmacovigilance and drug safety management (both clinical trial and post-marketing).

  • Proficient in processing ICSRs and literature search/review.

  • Ability to perform signal detection, manage regulatory submissions, and ensure compliance with reporting requirements.

  • Knowledge of regulatory guidelines and SOPs in pharmacovigilance.