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Sr. Scientist, Global Pv Aggregate Reporting-2407029246w

3+ years
Not Disclosed
10 Jan. 15, 2025
Job Description
Job Type: Full Time Education: MS/MPH,/MSN/PharmD/RPh/PhD 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

Sr. Scientist, Global PV Aggregate Reporting - Job ID 2407029246W

Location: High Wycombe, England
Job Function: Drug & Product Safety Science

Kenvue is looking for a Senior Scientist in Global Pharmacovigilance Aggregate Reporting to lead core safety deliverables, including scheduled aggregate safety reports, Risk Management Plans (RMPs), and Company Core Data Sheets (CCDS) for Kenvue products.

Key Responsibilities:

  • Oversee and collaborate with stakeholders on the development of safety reports and strategies.
  • Manage aggregate safety analysis and case-level review, ensuring quality reports and compliance with global pharmacovigilance regulations.
  • Prepare and contribute to the development of core safety deliverables.
  • Work with vendors and internal teams to ensure timely and accurate data collection for aggregate reporting.
  • Lead cross-functional training and provide expertise during audits/inspections.
  • Maintain global pharmacovigilance processes and procedures to comply with regulatory requirements.

Required Qualifications:

  • Bachelor’s degree in health/life sciences.
  • 3+ years of experience in the pharmaceutical industry, with at least 2 years in pharmacovigilance.
  • Strong clinical/medical writing experience.
  • In-depth knowledge of global pharmacovigilance regulations (e.g., ICH, GVP).
  • Strong analytical, problem-solving, and communication skills.

Desired Qualifications:

  • Advanced degree (e.g., MS, PharmD, PhD).
  • Experience in drug safety policy development and aggregate report writing.
  • Leadership skills and the ability to manage multiple projects in a fast-paced environment.

Benefits:

  • Competitive benefits package.
  • Learning and development opportunities.