In this position you will act as the Subject Matter Expert all pharmacovigilance activities at IMV and be responsible for the timely collection, assessment and submission of adverse event (AE) reports within the established time frames and in compliance with global regulatory requirements. You will also be responsible for creating and maintaining tracking in IMV safety database and routinely provide metrics, while performing other pharmacovigilance operational tasks as required. Including SOP preparation, eCTD compliant documents and safety reports. You will work closely and collaboratively with IMV teams and consultants to ensure that appropriate processes and structure are in place to enable a compliant pharmacovigilance system.
What you'll do
- Acts as a subject matter expert in all matters pertaining to Pharmacovigilance (PV) regulation for USA, Canada and EU and Good Pharmacovigilance Practices (GVPs).
- Maintains close working connections with IMV 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 effectively ensures timely communication of all related Regulatory intelligence to the Regulatory Affairs Manager and VP
- 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 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, as it related to PV activities, in collaboration with the Quality team.
- Prepares the safety information for monthly and annual reports in cooperation with the Clinical team. Where applicable ensures Health Authority submission compliance of Aggregate Reports (e.g. DSUR).
- Responsible for timely Safety submissions of AE reports, initial and follow-up to the Regulatory agencies and external partners.
- Works closely with the Clinical team and other concerned IMV teams to compile a response to Safety reports Information requests by Regulatory Agencies.
- Participates in the preparation of Safety Management Plans.
- Works with the Clinical team to draft the Development of Overview of Safety, Benefits and Risks Conclusions, and the Summary of Clinical Safety CTD sections as needed, 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.
AE databases and trending
- Works closely with the Clinical team and external consultant 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 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.
What you'll need
A Bachelor degree or advanced diploma in a life science; post-graduate certificate in RA, Pharmacovigilance etc. is an asset
At least 5 years of experience in regulatory affairs and/or regulatory operations supporting the clinical and pharmacovigilance activities
2 years of experience in preparation of eCTD compliant regulatory submissions
Experience in development of biologics (vaccine, oncology)
Additional PV training will be provided
A little bit about us
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, 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).
Our Platform Enables a Strong, Sustained Immune Response
The unique "no-release" mechanism of action of our DPX Platform allows antigen-presenting cells (APCs) to be attracted to the injection site, facilitating antigen presentation to immune cells. All our immunotherapies and vaccines candidates are formulated with the DPX platform, giving them the ability to generate, in vivo, a targeted, robust and sustained immune response against cancer cells or viruses.
Are you interested?
Work With Us
This position can be based in Quebec City, QC or in Dartmouth, NS with remote working arrangements.
Please indicate in your application, your salary expectations and your availability for this position.
Compensation will be determined based upon skill set and experience of the selected candidate and benchmarking for the position. IMV offers paid vacation, health/ dental plan, employee assistance program, stock options, and annual bonuses.
If you feel that you are the best candidate for this position, please apply through the "Apply Now" button.
Please clearly indicate in your application how you meet the requirements for this role and why you think you would be the best candidate for the role.
Applications will be considered upon receipt until October 23rd 2020
*We appreciate your application but only candidates selected for interviews will be contacted. We reserve the right to request interview candidates to complete skill/ behavior based assessments as part of the interview process.
Strong Science Needs Bright Minds
At IMV, we have high standards. And even higher aspirations.
Our drug candidates are helping us build on this promise. Our technology provides the tools that underscore this mission. And our people are the heart of our operation-the ultimate value-drivers upon which we, as a Company, rest.
We Work Better Together
Curing diseases-especially the ones that continue to evade and outpace even the brightest minds in our industry-is hard work. Despite the intensity and ferocity of our business, the one thing we do not have to worry about is the morale and the spirit of our people. We work hard and we play hard. Our people enjoy our drive, our mission and the road less traveled here in Halifax. As it turns out, that does make all the difference.
We aim high with our mission, so we expect high performance from our people. Whether you are evaluating T cell responses, coordinating clinical operations with our partners, or working with our investor base, we depend on you to help realize the full value of our organization. In turn, we value you, and what you can bring to our Company. We support you in enjoying life fully while working towards your professional goals. Above all, we cultivate the camaraderie that is the hallmark of our corporate culture.
Happy Employees Produce Strong Results.