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Pv Assistant Manager, Aggregate Report Writing

Pharmalex
PharmaLex
5+ 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 specializing in Aggregate Report Writing, you will be responsible for the development, authorship, and tracking of Safety Reports (PSUR/RMP/ACOs). Your key responsibilities include:

  • Safety Report Development: Ensure high-quality, regulatory-compliant documents by initiating tracking of commitments and liaising with relevant functions to monitor progress.
  • Operational Implementation: Oversee operational tasks related to safety writing and ensure service performance meets expectations.
  • Mentorship: Mentor employees to empower them to work independently within timelines, budgets, and quality standards.
  • Kick-off Meetings: Organize kick-off meetings, prepare PSURs and RMPs according to client SOPs, and review documents for medical cohesiveness and safety concerns.
  • Document Authorship: Collaborate with teams to develop high-quality, regulatory-compliant PSURs, PBRERs, RMPs, ACOs, and DSURs.
  • Coordination: Coordinate activities across different units to include all necessary documents to support the main RMP/PSUR/ACO.
  • Logistical Management: Manage all logistical aspects for timely development of safety reports, ensuring content meets client and Health Authorities’ requirements.
  • Regulatory Updates: Update RMPs according to Health Authority requirements and ensure alignment with other regulatory documents, such as PSURs and CDS.
  • Compliance Tracking: Track Health Authorities' feedback on RMPs, PSURs, and ACOs, ensuring that all requirements are implemented.
  • Document Maintenance: Ensure proper maintenance of all RMP, PSUR, and ACO documents as per established processes.
  • Training Development: Develop and dispatch product-specific training materials for internal teams and third parties, ensuring timely updates approved by Health Authorities.
  • Quality Control: Conduct peer reviews and populate QC checklists, addressing comments from various stakeholders.
  • Regulatory Responses: Prepare responses to Health Authority inquiries and formulate strategies for safety issues, including integrated benefit-risk evaluations.

Your Profile:

  • Experience: Minimum 5 years in aggregate report authoring (Innovators).
  • Qualification: B.Pharm, M.Pharm, BDS, or Pharm D.

If you are interested in joining our Pharmalex team for 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.