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Sr. Pv Associate

Indivirtus Healthcare Services
Indivirtus Healthcare Services
3-5 years
5-7 Lacs per annum
10 Sept. 4, 2024
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 Drug Safety Associate

Job Description:

The Senior Drug Safety Associate will provide both technical and process-related support for drug safety management in clinical trials and post-marketing activities. You will ensure adherence to relevant regulations and Standard Operating Procedures (SOPs).

Key Responsibilities:

  • Process Individual Case Safety Reports (ICSRs) from various sources.
  • Conduct literature searches and reviews.
  • Perform signal detection and management.
  • Track regulatory information and handle regulatory submissions.
  • Support the preparation of aggregate reports and other study documentation.
  • Manage Medical and Product Dictionaries, as applicable.

Compliance and Quality Assurance:

  • Ensure ICSR compliance and related processes, including quality review of ICSRs.
  • Generate metrics and investigate late cases in accordance with international and local regulatory reporting requirements, where applicable.

All applications should be sent to ashok@indivirtusab7.com