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Case Specialist

Remote:

Full Remote

Experience:

Mid-level (2-5 years)

Work from:

Greece

Offer summary

Qualifications:

Degree in Pharmacy, Minimum 2 years of experience in pharmacovigilance, Knowledge of GCP and GVP, Proficiency with Microsoft Office suite.

Key responsabilities:

Collect information on side effects
Review and assess safety reports
Document detailed case reports
Submit safety reports to regulatory agencies

ProductLife Group http://www.productlifegroup.com/

1001 - 5000 Employees

See more ProductLife Group offers

Job description

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
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