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Drug Safety Specialist

3-5 years
Not Disclosed
10 Jan. 21, 2025
Job Description
Job Type: Remote Education: B.Sc, M.Sc, B.Pharm, M.Pharm and LifeScience Graduates 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 Drug Safety Specialist
Employer: Barrington James
Location: Remote/Flexible (EU-based only)
Contract Type: 6-Month Contract (20 Hours/Week)
Salary: Competitive
Start Date: 28th January 2025
Closing Date: 13th February 2025


Job Overview:

Barrington James is seeking an Interim Drug Safety Specialist for a 6-month contract. This remote position is open to candidates based in the EU. The successful candidate will be responsible for managing drug safety processes, including the review and processing of Individual Case Safety Reports (ICSRs), preparation of safety reports, and supporting risk mitigation efforts.


Key Responsibilities:

  • ICSR Management: Collect, review, and process Individual Case Safety Reports (ICSRs) in compliance with regulatory timelines and internal Standard Operating Procedures (SOPs).
  • Data Entry & Record Maintenance: Ensure accurate data entry into safety databases and maintain detailed records of all activities.
  • Signal Detection: Assist in the identification and analysis of potential safety signals.
  • Safety Reporting: Support the preparation and submission of safety reports, including Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
  • Regulatory Liaison: Communicate with regulatory authorities to address queries related to drug safety.
  • Risk Management: Contribute to the development and review of Risk Management Plans (RMPs).
  • Clinical & Post-Marketing Safety: Provide input on safety aspects during clinical trials and post-marketing phases.
  • Compliance: Ensure adherence to Good Pharmacovigilance Practices (GVP).

Qualifications and Skills:

  • Education: Bachelor’s degree in pharmacy, life sciences, or a related field; advanced degree preferred.
  • Experience: At least 3-5 years of experience in pharmacovigilance/drug safety, including experience with case processing and regulatory submissions.
  • Technical Skills: Proficiency in using pharmacovigilance databases and tools.
  • Regulatory Knowledge: Familiarity with global regulatory guidelines (e.g., EMA, FDA, ICH).
  • Analytical Skills: Strong analytical skills with attention to detail.
  • Communication Skills: Excellent written and verbal communication skills.
  • Remote Work: Ability to work independently and manage time effectively in a remote environment.

How to Apply:

Interested candidates should apply by 13th February 2025.


Closing Date for Applications: 13th February 2025