Zymeworks Biopharmaceuticals Inc. Director, Safety Science in Seattle, Washington
DescriptionZymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks' suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.About the positionZymeworks is seeking a highly-motivated professional who is looking to grow their career with our company. The Director, Safety Science will develop and lead surveillance activities and provides scientific/clinical/pharmacovigilance expertise for safety data analysis from various sources including pre-clinical studies, clinical studies, literature and other information sources. This individual will focus on the pro-active identification, evaluation, and risk management of safety risks to patients for assigned Zymeworks' products throughout the product's life cycle.This position will report to the Senior Director, Safety Science and will be a remote position.Key ResponsibilitiesLead proactive pharmacovigilance signal detection and risk management planning for designated Zymeworks products, including signal identification, evaluation, interpretation of safety signals and trends and communication (written and verbal) of safety risksLead and/or participate in preparation aggregate safety data such as DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans under the guidance of the Senior Director, according to the agreed process and timelinesLead and/or manage in the Safety Management Team (SMT) including setting agenda, producing necessary data outputs, facilitating discussions, and documenting conclusionsLead and/or Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g., Developmental Core Safety Information [DCSI] Company Core Safety Information [CCSI], Investigator Brochure [IB], etc.); the production and/or contribute to responses for regulatory or other ad-hoc safety queries; includes proposing response strategies, review of relevant data, and authoring of responsesCollaborate with other applicable functional area specialists including with Clinical Research, Regulatory Affairs, Biostatistics and Data Management, Translational Medicine, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs), Safety Management Committees, business partners and other entities, as needed, to evaluate and manage safety signals for ZW products; provide support to cross-functional ad-hoc teams set up to address urgent and important safety issuesLead and/or participates in the preparation and review of safety risk section(s) of Investigator brochures (IBs), protocols, informed consent/assent forms, clinical study reports/synopses, Integrated Summary of Safety )/Common Technical Document (CTD) submissions and other documents as needed; ensure risk-reduction strategies are implemented timely and appropriately in relevant documentsPerform individual case safety report (ICSR) medical review to include, accessing the Argus safety database to perform medical review; ensuring medical completeness and accuracy, MedDRA coding, identifying queries and preparing analysis of similar events (AOSE) as required. Maintain knowledge of disease states for therapeutic area(s) for assigned productsDemonstrate knowledge and ensure compliance with current and applicable global PV regulations/guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.)and with corporate and departmental policies and proceduresSynthesize data from multiple sources using critical thinking skills and communicate complex clinical information and safety data to healthcare professionals (HCPs) and non-HCPs.