Case Specialist

We are seeking a dedicated and experienced Case Specialist to join our Pharmacovigilance team. The ideal candidate will play a key role in supporting post-marketing pharmacovigilance operations by reviewing, assessing, and managing safety reports.

Responsibilities

1. Collect Information

• Gather reports of side effects or adverse events experienced by patients and source information from healthcare providers, patients, and healthcare systems regarding potential drug-related issues

2. Review Cases

• Perform a medical review of safety reports to evaluate whether the drug may be causing the side effects
• Analyze each case thoroughly, considering the patient’s medical history, dosage, and timing of the reaction
• Address queries and conduct further assessments when necessary to clarify the nature of adverse events

3. Document

• Create detailed case reports, ensuring all information is accurately recorded and in compliance with regulatory guidelines
• Maintain up-to-date documentation and ensure proper data entry into pharmacovigilance databases

4. Report to Authorities

• Submit safety reports to regulatory agencies such as the FDA, EMA, or relevant national authorities
• Ensure timely and accurate submission of all post-marketing cases as required by Good Pharmacovigilance Practices (GVP) and other regulations
• Communicate regularly with stakeholders to keep them informed about safety case statuses and resolve any queries

Experience

• Degree in Pharmacy or a related field
• Minimum 2 years of experience working in pharmacovigilance or a related field (for EU positions)
• Proven ability to meet deadlines and work efficiently under pressure
• Client communication experience, with a focus on pharmacovigilance matters
• Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP)
• Proficiency with the Microsoft Office suite (Word, Excel, PowerPoint)
• Experience working with pharmacovigilance databases (Argus)
• Effective communication skills, both written and verbal
• Organized, reliable, and punctual, with a strong attention to details
• Knowledge of French is useful but not required