Senior Analyst, GBS-GPV

Job Summary

Global Pharmacovigilance (PV) is an operating department within Global R&D. The Global PV department is involved in the processing & submission of adverse drug reaction reports & safety data management to support the development & commercialization of Apotex products in the markets in which we do business, in compliance with global PV regulations & relevant ICH guidelines.

Job Responsibilities

Primary responsibilities

• Support PSRM activity by screening & identifying articles of interest for potential signals & aggregate reports from published literature Embase hits. Conducts review of published literature Embase hits to identify ICSRs and other events of special interest.
• Perform precision-based data structured field, Quality reviews of ICSRs to ensure compliance with Apotex data entry & processing conventions including, but not limited to, narrative compilation, MedDRA coding assessments & causality assessments.
• Perform review of ICSRs, to ensure ICSRs processed in compliance with applicable departmental SOPs & conventions, including but not limited to the review of FU attempts.
• Challenge ICSR level data quality issues & non-compliance to conventions/SOPs with the Service Provider.
• Perform submission of ICSRs to regulatory authorities, Apotex affiliates & Business partners in accordance with departmental SOPs & HRA legislation.
• Timely response to queries related to ICSRs from stakeholders Maintain departmental document management, including scanning & filing of source

Supporting responsibilities

• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, & Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics & Compliance Program, Global Quality policies & procedures, Safety & Environment policies, & HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • PharmD, MPharm, Nursing or related Health Science discipline
• Knowledge, Skills & Abilities
  • Excellent English oral/written communication.
  • Knowledge of MedDRA, ARGUS & literature review preferred
  • Organizational & interpersonal skillsKknowledge of relevant local & international PV regulations & ICH guidelines on safety data management in clinical trials & post-approval
  • Knowledge of Microsoft Office: Excel, PowerPoint, Word
• Experience: These will be duly updated as per applicable roles.
  • PV experience across safety operations: at least 2-3 years’ pharmaceutical experience in a PV role
  • Quality Review & Submissions: Preferred experience of at least 1-2 years on submission of ICSRs globally
  • Literature Validation: Preferred experience of at least 1-2 years on literature validation/literature case processing