Global Pharmacovigilance Scientist

Barrington James

0-2 years

Not Disclosed

10 Jan. 21, 2025

Job Description

Job Type: Full Time 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 Global Pharmacovigilance Scientist
Employer: Barrington James
Location: Remote (European-based consultants only)
Contract Type: 6-Month Contract (30 Hours/Week - 0.75 FTE)
Salary: Competitive
Start Date: 16th January 2025
Closing Date: 15th February 2025

Job Overview:

Barrington James is seeking an Interim Global Pharmacovigilance Scientist for a 6-month contract. This remote role (for European-based consultants only) involves working in pharmacovigilance activities, focusing on case processing, regulatory reporting, safety data analysis, and collaborating with cross-functional teams.

Key Responsibilities:

Case Processing: Perform case processing tasks, including data entry, quality review, and follow-up on Individual Case Safety Reports (ICSRs).
Adverse Event Reporting: Ensure timely and accurate reporting of adverse events to regulatory authorities, partners, and internal stakeholders.
Compliance Monitoring: Monitor compliance metrics and assist in resolving deviations from regulatory or internal standards.
Audits & Inspections: Participate in audits and inspections, providing required data and documentation as needed.
Regulatory Reporting: Prepare and submit Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and other regulatory documents.
Regulatory Responses: Support the preparation of responses to inquiries from regulatory authorities.
Signal Detection & Management: Collaborate with the safety surveillance team to support signal detection and management activities.
Safety Data Analysis: Assist in the analysis and evaluation of safety data trends to identify potential safety signals.
Cross-functional Collaboration: Liaise with internal teams (clinical, medical affairs, regulatory) and external partners (CROs, affiliates) to ensure alignment in pharmacovigilance operations.
SOP Maintenance: Contribute to the update and maintenance of Pharmacovigilance Standard Operating Procedures (SOPs) and work instructions.

Qualifications and Skills:

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

How to Apply:

If you meet the qualifications and are interested in this interim role, please submit your application by the closing date of 15th February 2025.

Closing Date for Applications: 15th February 2025

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Global Pharmacovigilance Scientist

Job Description

Job Overview:

Key Responsibilities:

Qualifications and Skills:

How to Apply:

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