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Sr. Pv Associate

3-5 years
Not Disclosed
10 Feb. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/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

Pharmacovigilance Sr. PV Associate

Job Responsibilities:

  • Provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities.
  • Ensure compliance with relevant regulations and Standard Operating Procedures (SOPs).
  • Process Individual Case Safety Reports (ICSRs) from various sources.
  • Conduct literature search and review, signal detection, and management.
  • Track regulatory information and perform regulatory submissions.
  • Support the preparation of aggregate and other study reports.
  • Manage Medical and Product Dictionary activities, where applicable.
  • Ensure ICSR compliance and related processes, including quality review of ICSRs, metrics generation, and late case investigation.
  • Adhere to International and local regulatory reporting requirements.

Experience Required: 3-5 years of relevant experience.

Salary: 20-25% rise on current CTC.