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Position Summary
The
Data Officer is responsible for the accurate processing, triage, and entry of pharmacovigilance data in compliance with regulatory requirements and company procedures. The role involves managing safety case information, supporting Individual Case Safety Report (ICSR) submissions, maintaining mailbox activities, conducting follow-up with consumers and patients, and supporting XEVMPD-related activities.
The successful candidate will demonstrate strong attention to detail, organizational skills, and the ability to work effectively within a dynamic pharmacovigilance environment.
Key Responsibilities
- 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 activities.
Required Education
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Biology, or a related scientific discipline.
Required Experience
- Minimum 2 years of experience in pharmacovigilance data entry within a post-marketing environment.
- Experience handling and processing ICSRs.
- Proven experience with XEVMPD activities.
Required Languages
- Excellent written and verbal communication skills in English.
- Additional languages are considered an asset.
Required Technical Skills
- 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.
Preferred Qualifications
- 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.
Key Competencies
- Attention to Detail
- Customer Focus
- Accountability
- Teamwork and Collaboration
- Communication Skills
- Problem Solving
- Planning and Organization
- Quality Orientation
