Data Officer (IN)
ProductLife Group (PLG) is a global consulting and outsourcing company supporting life sciences organizations throughout the product lifecycle.
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 activitie
Requirements:
Required Education
- Bachelorโs degree in Life Sciences, Pharmacy, Biotechnology, Biology, or a related scientific discipline.
Required Experience
- Minimumย 2 years of experienceย in pharmacovigilance data entry within a post-marketing environment.
- Experience handling and processing ICSRs.
- Proven experience withย XEVMPD activities.
Required Languages
- Excellent written and verbal communication skills inย 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
Quality Orientation
Attention to Detail
Customer Focus
Accountability
Teamwork and Collaboration
Communication Skills
Problem Solving
Planning and Organization
HOW TO APPLY
