30 Jul
|
ProductLife Group
|
India
30 Jul
ProductLife Group
India
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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 setting.
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 a
📌 Data Officer (India)
🏢 ProductLife Group
📍 India