Type: Permanent full time
Location: Montreal - Head Office
Department: Medical and Regulatory Affairs
Reports To: Director, Regulatory Affairs, QA, PV & MI
Summary of Purpose:
This position’s primarily responsibility is the management of operational activities related to pharmacovigilance (PV) for OCPI. The candidate will establish close relationships with internal colleagues at both local and global levels, and with many other bodies, such as, major external vendors providing services to fulfill PV requirements, alliance partners and other third-party service providers, when applicable. The candidate will provide support for existing products on the Canadian market, as well as products in the pre-launch phase or other special cases.
The candidate will act as the Local Safety Manager (LSM) for OCPI.
- Collect, process and forward Individual Case Safety Reports (ICSR) to global PV according to relevant global and local standard operating procedures (SOPs), working practices (WPs) and applicable agreements.
- Perform follow-up on ICSRs, including pregnancy cases, as per relevant SOPs/WPs.
- In case ICSRs submissions to local competent authority cannot be performed centrally (such as via E2B) or if local regulations require submissions to be performed locally, perform ICSRs submissions to Health Canada as per applicable SOPs and agreements.
- Report the significant, emerging safety issues to Health Canada as required.
- Set up annual PV training plan.
- Develop local PV training material (including basic PV training and PV training for studies/programs)
- Organize and conduct PV training as per relevant SOPs/WPs including the necessary training for all OCPI personnel (including new employees and refresher), investigators and site-staff involved in the studies/programs, and for third parties contracted by OCPI.
- Document and maintain all the PV training received and provided to others.
- Participate in PV training for LSMs.
- Prepare, maintain, and supervise implementation of current applicable regional and global SOPs/WPs to ensure compliance with regional PV procedures, as needed. Ensure all local SOPs/WPs are compliant with local regulatory PV requirements which go beyond those covered by applicable regional and global SOPs.
- Prepare, review, update, and maintain PV clause in local contracts and agreements ensuring safety language is included, and participate in the development, negotiation, and maintenance of PV agreements.
- Review active local contracts to confirm that any PV-related activities in the contracts meet the latest Otsuka global good practice (GxP)/PV glossary and global/regional/local PV reporting requirements or standards.
- Inform relevant global/regional PV function immediately of any situations at OCPI or contracted third parties which prevent compliance with applicable PV SOPs, regulatory PV requirements and agreements.
- Manage and conduct oversight of submission and archiving of received aggregate reports (e.g., Annual Summary Reports, PSUR, PBRER, and/or DSUR). Ensure submission of aggregate reports to the applicable local regulatory authorities. Notify the submission to the responsible local team and global PV.
- Manage and/or conduct oversight of RMP-related PV activities including risk minimization measures (RMMs).
- Identify ICSRs detected by local literature search based on Otsuka medicinal products/devices and send the ICSRs according to relevant SOPs/WPs. Maintain a list of local journals selected to be reviewed according to the applicable regional and/or local SOPs/WPs in the local search area and document the search.
- Review Otsuka product-related study documents from a PV perspective (e.g., protocol, protocol synopsis, CSR, CSR synopsis, draft of publication article, global study list, etc.).
- Manage promotional material (e.g., review, approval, etc.) from a PV perspective.
- Inform regional PV function immediately of any clinical trial or study, or any compassionate or named patient use program being conducted in Canada which involves an OCPI product, whether sponsored by OCPI or by a third party.
- Oversee safety information reconciliation activities with relevant teams such as product quality complaints, medical inquiries, and social media committee.
- Oversee vendors performing PV activities on behalf of Otsuka in accordance with applicable regulations, agreements, and SOPs/WPs.
- Manage PV-related audit/inspection activities and ensure execution of deviations and CAPA management.
- Ensure that all PV-related documents, including ICSRs and associated documents and PV-related nominations, are retained permanently.
- Develop and maintain a PV business continuity plan in accordance with corresponding global SOP.
- Maintain current knowledge of all local regulatory PV requirements in Canada, communicate with relevant global/regional PV and ensure compliance with them.
- Inform regional PV function immediately of any change in contact information, or of temporary or permanent discontinuation as LSM.
- Manage response to local health authority’s PV-related queries/requests according to relevant SOPs/WPs.
- Conduct oversight of any other PV-related work as needed.
- Reporting Safety Information, Product Quality Complaint, Medical Device Incident Reports, and Customer Feedback as per training on current procedures.
- Oversee PV functional budget, monitor and manage expenses as well as third party (contractors/consultants and vendors) work and deliverables.
* In the event of delegation of responsibilities, oversight is provided.
Qualifications and Key Competencies:
- Sc. degree in a scientific field with significant pharmaceutical industry experience in PV
- Must be bilingual, French and English, written and spoken
- Outstanding writing, oral and interpersonal skills
- Well-organized, strong ability to handle multiple projects and priorities simultaneously and function in a fast-paced environment while maintaining a keen eye for detail
- Must be able to work independently, requesting assistance in the event of unusual circumstances
- Ability to form effective relationships with a wide range of groups and individuals and work effectively in a team (including the ability to serve as a role model for activities)
- Excellent interpersonal communication and presentation skills (including ability to network), strong personal integrity and a customer focus are necessary
- Proficient in Microsoft applications, including Word, Excel and PowerPoint.
- Analytical and problem-solving skills
- Strong customer-oriented attitude, team spirit and ability to establish effective relationships
- Desire to learn
Supervision of Others: Local Safety Manager