Data Officer
Groupe ProductLife
Wettolsheim, France
8 days ago
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Role details
Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Experienced
Experience required
2 years minimum
Working hours
Regular working hours
Languages
English
Job source
Tech stack
Microsoft Word
Microsoft Excel
Microsoft Outlook
Databases
Microsoft Office
Microsoft PowerPoint
Data Management
Job description
- Perform triage, review, and data entry of pharmacovigilance cases.
- Process and maintain Individual Case Safety Reports (ICSRs) in accordance with applicable regulations and internal procedures.
- Support the submission of ICSRs to health authorities, clients, and partners.
- Manage and monitor assigned pharmacovigilance mailboxes.
- Follow up directly with consumers, patients, healthcare professionals, and other stakeholders to obtain missing safety information when required.
- Perform XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) related activities.
- Ensure data accuracy, completeness, and consistency across safety databases.
- Maintain compliance with quality standards, SOPs, and regulatory requirements.
- Collaborate effectively with cross-functional teams and stakeholders.
- Support continuous improvement initiatives and operational excellence activitie
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Biology, or a related scientific discipline., * Minimum 2 years of experience in pharmacovigilance data entry within a post-marketing environment.
- Experience handling and processing ICSRs.
- Proven experience with XEVMPD activities., * Excellent written and verbal communication skills in English.
- Additional languages are considered an asset., * Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
- Strong attention to detail and data accuracy.
- Excellent organizational and time-management skills.
- Process-oriented mindset.
- Ability to work effectively in a team environment.
- Flexibility and adaptability in a fast-paced setting., * Experience working with pharmacovigilance databases.
- Knowledge of regulatory pharmacovigilance requirements.
- Previous exposure to safety database management systems.
- Additional experience with XEVMPD maintenance and data management.
- Database experience is preferred; training will be provided where needed., * Attention to Detail
- Customer Focus
- Accountability
- Teamwork and Collaboration
- Communication Skills
- Problem Solving
- Planning and Organization
- Quality Orientation
About the company
ProductLife Group (PLG) is a global consulting and outsourcing company supporting life sciences organizations throughout the product lifecycle.
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