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

Data Officer

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