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Pv Assistant Manager

Pharmalex
PharmaLex
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 a PV Assistant Manager, you will be responsible for overseeing the management and documentation of assigned Pharmacovigilance (PV) projects. Your key responsibilities include:

  • Project Management: Coordinate and allocate tasks within assigned projects to ensure smooth operations.
  • Training and Mentorship: Train and mentor PV department staff as needed, fostering their professional growth.
  • Invoice Management: Ensure that monthly invoices are generated and shared regularly with all PV clients.
  • Documentation Oversight: Maintain up-to-date departmental CVs, job descriptions, and training records in accordance with SOPs.
  • Training Compliance: Ensure all PV staff comply with training requirements at all times.
  • Audit Representation: Represent the PV department during client audits or regulatory inspections.
  • Quality Assurance Documentation: Write and review QA documents, including SDEAs, SOPs, Working Instructions, and templates for PharmaLex PV projects.
  • Training Organization: Organize and conduct training on the aforementioned documents.
  • Case Processing: Handle data entry and quality control for case processing.
  • Follow-Up Requests: Prepare and send follow-up requests and ensure thorough documentation of cases.

Your Profile:

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

If you are interested in joining our Pharmalex team and taking on this challenging opportunity in a forward-thinking company, we look forward to receiving your application, including your earliest possible start date, any visa requirements, and salary expectations.