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Pv Assistant Manager

5-8 years
Not Disclosed
10 Oct. 29, 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

Your Job:
As the PV Assistant Manager, you will oversee the management and documentation for assigned pharmacovigilance (PV) projects. Your responsibilities include:

  • Project Management: Coordinate and allocate resources for PV projects, ensuring efficient workflow.
  • Staff Training: Train and mentor PV department staff as needed.
  • Invoicing: Ensure that monthly invoices for all PV clients are generated and distributed regularly.
  • Compliance Oversight: Maintain up-to-date departmental CVs, job descriptions, and training records in accordance with SOPs.
  • Training Compliance: Ensure that PV staff are compliant with training requirements at all times.
  • Audit Representation: Represent the PV department during client audits and regulatory authority inspections.
  • Document Review: Write and review QA documents, including SDEAs, Working Instructions, SOPs, and templates for PharmaLex PV projects.
  • Training Organization: Organize and conduct training on the aforementioned documents.
  • Case Processing: Handle case processing, including data entry and quality control (QC).
  • Follow-Up Requests: Prepare and send follow-up requests as needed.
  • Case Documentation: Complete and document cases accurately.

Your Profile:

  • Qualification: B.Pharm, BDS, Pharm D, or M.Pharm.
  • Experience: Minimum of 5-8 years in pharmacovigilance.

If you are interested in this opportunity with PharmaLex, we look forward to receiving your application.