(Senior) Director, Drug Safety and Pharmacovigilance Operations

Job description

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. We are looking for an accomplished Pharmacovigilance (PV) Leader to spearhead the evolution of our drug safety framework as we enter Phase 3. Balancing strategic oversight of external partners with hands-on systems building, you will uphold the highest standards of scientific integrity and regulatory compliance to pave the way for successful regulatory filings and commercial launch. **How you might spend your days** - Collaborating with external partners, CROs, and affiliates to manage PV vendors and agreements, and Safety Management Plans as needed, to ensure consistent safety practices, reporting, and compliance across all programs - Providing expert oversight for safety data review, including aggregate analyses, working closely with Regulatory Affairs to produce and submit periodic safety reports (e.g. DSURs, PSURs), individual reports (SUSARs, CIOMs), and responses to regulatory queries - Working with Medical Monitors and Clinical Scientists to facilitate comprehensive safety signal detection, validation, and management, ensuring timely escalation and resolution of potential safety issues - Ensuring robust safety surveillance through continuous monitoring of emerging safety data from clinical trials, literature, and external databases - Overseeing global PV systems and processes, including case processing and aggregate reporting, ensuring compliance with international regulations (FDA, EMA, HC, etc.) - Leading safety-related elements of inspection readiness and managing responses to audits, regulatory inquiries, and corrective action plans - Working with Clinical Quality to develop and maintain SOPs and safety governance frameworks, to ensure operational excellence and regulatory compliance - Staying abreast of evolving global safety regulations, guidelines, and best practices - Partnering closely with Clinical Development, Regulatory Affairs, Medical Affairs, Manufacturing, and Quality to ensure integrated safety oversight and seamless execution of safety strategies - Driving the development and execution of risk management plans, safety specifications, and benefit-risk assessments for regulatory submissions and ongoing clinical programs **W****e’d love to hear from you if** - You have a proven track record in global safety strategy, PV operations, and regulatory engagement, ideally within the monoclonal antibody space - You have at least 12 years of relevant work experience in drug safety/PV, in addition to a relevant post-secondary degree(s) in healthcare (RN, PharmD, PA, or NP) - You have experience with safety databases (e.g., ARGUS, ARISg, Veeva Vault Safety) - You have a demonstrated track record managing global regulatory PV submissions and health authority interactions (FDA, EMA, and Health Canada) - You have an expert-level knowledge of global PV regulations and guidelines (e.g. 21 CFR 312/600, ICH E2A–E2F, GVP modules, WHO guidelines) - You have prior experience building or scaling a pharmacovigilance function (preferred) **W****hat we offer** AbCellera’s hiring range for the Director role is CAD $160,000 - $200,000 annually and the range for the Senior Director role is CAD $200,000 - $245,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, an annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution. You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship are a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials. **A****bout AbCellera** ***Creating medicines is the most important work we can do.*** We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications. We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience. We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines. **To apply** Please submit your application through our website and refer to **Job ID 23390** in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.