Opportunity: Director, Global Pharmacovigilance
Location: Canada or United States
IMV Inc. is a clinical-stage pharmaceutical company that has the potential to make history by developing a first-in-class effective T cell-targeted immune therapy for cancer. We have built an unprecedented delivery platform (DPX) that generates targeted immune cells directly into the human body, which produces robust, and sustained capabilities to destroy cancer. DPX is the engine that drives our lead drug candidate, Maveropepimut-S (DPX-Survivac), which has successfully completed multiple Phase 1/1b trials, generating best-in-class results in advanced recurrent ovarian cancer and Diffuse Large B Cell Lymphoma (DLBCL).
- Acts as a subject matter expert in all matters pertaining to Pharmacovigilance (PV) regulation for USA, Canada, EU and RoW, and Good Pharmacovigilance Practices (GVPs).
- Maintains close working connections with IMV Regulatory and Clinical Operation teams and provides operational recommendations to facilitate compliance with PV requirements (USA, Canada, and EU).
- Maintains a detailed understanding and continuous awareness of the regulatory intelligence associated to PV (e.g. regulations, directives, GVPs), and any updates or anticipated changes and plans for adjustments in IMV’s procedure and templates accordingly.
- Creates relevant SOPs and ensures appropriate PV processes are in place for the receipt, collection, and submission (as applicable) of Safety reports, literature review and Safety follow up.
- Maintains an up-to-date knowledge of local regulatory requirements for Safety Reporting and effectively ensures timely communication of all related Regulatory intelligence matters.
- Maintains a state of inspection readiness by maintaining appropriate documentation/evidence that demonstrates the efficient and compliant functioning of the IMV PV operations. Plays a lead role in the preparation, facilitation and coordination of internal/external audits and inspections in collaboration with the Quality team.
- Prepares the safety information for monthly and annual reports in cooperation with IMV Regulatory and Clinical Operation teams. Where applicable ensures Health Authority submission compliance of Aggregate Reports (e.g. DSUR).
- Coordinate with Regulatory Operation Safety submissions of AE reports, initial and follow-up to the Regulatory agencies and external partners.
- Works closely with IMV Regulatory and Clinical Operation teams, Clinical Advisors and other concerned IMV teams to compile a response to Safety reports Information requests by Regulatory Agencies.
- Participates in the elaboration, review and approve the Safety Management Plans.
- Supports the IMV RA team in the authoring and Development of Overview of Safety, Benefits and Risks Assessments, and the Summary of Clinical Safety CTD sections, as well as the Safety Specification of the product (non-clinical and clinical), Pharmacovigilance plan and Risk Managements Plans.
- Supports the RA team for preparation of documentation associated to the clinical and non-clinical development, regulatory submissions, meeting requests and briefing documents non-clinical and clinical information and other interactions with the regulatory agencies.
- Works closely with the IMV Regulatory and Clinical Operation teams, external consultant and /or CRO on the development of the IMV PV structure, safety reports database and related processes.
- Performs on-going RA review of adverse events reports, monitors trends, develops trending and analytics tools.
- Participate in recurrent reviews of Adverse events with the Clinical team and CROs and safety signals discussions.
- Authors and maintains PV-related SOP and training.
- Collaborates with the team to develop internal tools for the management of Safety submissions and preparation of eCTD compliant documents.
- Provides support to the regulatory team for the final packaging/publishing of regulatory submissions.
- At least 6-8 years of experience supporting the clinical and pharmacovigilance activities
- Experience in development of oncology or biologics products
- In depth understanding of the regulation / requirements, including Pharmacovigilance, supporting the development of biologic, oncology and/or vaccine in Canada, USA and Europe
- Excellent oral and written English with good communication skills
- Excellent skills with the Microsoft suites and Adobe
- Hands on experience for the preparation of eCTD compliant documents and e-Publishing would be an asset
- Solution and detail oriented
About Pender & Howe:
IMV has retained Pender & Howe to lead the recruitment initiative for the Director, Global Pharmacovigilance position.
Pender & Howe is a boutique retained executive search firm specializing in collaborating with governing boards and CEOs in identifying world class executive leaders. More information about Pender & Howe is available at www.penderhowe.com.
This search is led by Celine Chabee. For consideration, please email a copy of your CV in confidence to Celine Chabee at [email protected].