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
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