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Global Pharmacovigilance Scientist

3-5 years
Not Disclosed
10 Jan. 17, 2025
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: Interim Global Pharmacovigilance Scientist
Contract Type: 6-Month Contract (30 Hours/Week - 0.75 FTE)
Location: Remote (European-based consultants only)

Job Description

We are seeking an experienced Interim Global Pharmacovigilance Scientist to join our team for a 6-month contract. In this role, you will be responsible for case processing, including data entry, quality review, and follow-up on Individual Case Safety Reports (ICSRs), ensuring compliance with regulatory authorities and internal stakeholders. You will also contribute to the preparation of periodic safety update reports (PSURs), risk management plans (RMPs), and other regulatory documents.

Key Responsibilities:

  • Perform case processing tasks, including data entry, quality review, and follow-up on ICSR submissions.
  • Ensure timely and accurate reporting of adverse events to regulatory authorities, partners, and internal stakeholders.
  • Monitor compliance metrics, ensuring adherence to regulations and resolving deviations.
  • Assist in audits and inspections, providing necessary data and documentation.
  • Prepare and submit periodic safety update reports (PSURs), risk management plans (RMPs), and other required regulatory documents.
  • Support the preparation of responses to inquiries from regulatory authorities.
  • Collaborate with the safety surveillance team to support signal detection and safety management activities.
  • Assist in the analysis of safety data trends and evaluation.
  • Liaise with internal teams (clinical, medical affairs, regulatory) and external partners (CROs, affiliates) to ensure alignment.
  • Contribute to cross-functional meetings, providing updates on pharmacovigilance activities.
  • Maintain and update Pharmacovigilance Standard Operating Procedures (SOPs) and work instructions.

Qualifications and Skills:

  • Bachelor’s degree in a relevant scientific discipline (e.g., Pharmacy, Life Sciences, Nursing); advanced degree (e.g., MSc, PharmD) is preferred.
  • Minimum 3-5 years of experience in global pharmacovigilance or drug safety roles.
  • Familiarity with regulatory requirements such as FDA, EMA, and ICH guidelines.
  • Proficiency in safety databases (e.g., Argus, ArisGlobal, or similar).