Performs global Pharmacovigilance processes of the unit : Medical assessment and quality review of Individual case safety reports (ICSR), including submission to regulatory authorities as needed;
Compliance monitoring and tracking; Reconciliation; Literature review, and occasional case processing as needed. Contributes to drafting and review of aggregate reports and Risk Management plans on products developed and manufactured by Apotex, in compliance with global drug safety regulations and ICH Guidelines.
Interacts with health professionals and consumers and affiliate offices during investigation of all case reports. When required, participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities relating to Risk Management programs as required.
Perform medical review of ICSRs and generate follow-up questions as appropriate.
Conduct literature assessment for ADRs and medical review of articles.
Conduct causality assessments for safety cases reports.
MedDRA coding assessment
Perform expectedness and listedness assessment and ICSR reportability.
Conduct quality review of ICSRs.
Contribute to submissions of ICSRs when required.
Assist in the preparation, review and evaluation of signals, aggregate reports and risk management plans
Contribute in generating responses to regulatory authority requests on product safety related issues for marketed products or product in development.
Respond to queries from clients (including internal and external to Apotex Inc.) in a timely manner.
Perform monthly or quarterly reconciliations of reports as required.
Assist in the maintenance of unit SODs, Safety Data Exchange agreements with business partners and internal work instructions.
Maintain departmental document management, including scanning and filing of source documents.
Contribute to maintenance and compliance oversight of PV processes, external service providers and business partners. May contribute to preparation and training of internal and external customers on adverse events reporting
Escalates to Project Leader, calls and requests for Health Care Professional consultation involving safety issues.
Contribute to process improvement initiatives in consultation with management.
Works as a member of a team to achieve all outcomes.
Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values.
Performs all work in accordance with all established regulatory and compliance and safety requirements.
All other duties as assigned.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.