$80K — $100K *
Zymeworks 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 Position
In conjunction with the safety physician, the Safety Scientist performs safety 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. The Safety Scientist 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, Drug Safety and Risk Management. This is a remote opportunity and we are looking for a candidate based in the US.
• In conjunction with the Senior Director and/ or other designees , support 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 risks
• Prepare and author reports of aggregate safety data such as DSURs, 6 monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, 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 timelines
• Key member of the Safety Management Team including setting agenda, producing necessary data outputs, facilitating discussions, and documenting conclusions
• 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.); co-ordinates meetings and tracks timelines to ensure completion
• Support responses for regulatory or other ad-hoc safety queries in collaboration with Sr. Director; includes proposing response strategies, review of relevant data, and authoring of responses
• Collaborate 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), 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 issues
• Contribute to 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 documents
• Maintain knowledge of disease states for therapeutic area(s) for assigned products
• Identify opportunities for, or the need to, enhance existing processes through knowledge of internal and external environment
• Demonstrate 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 procedures
• Synthesize data from multiple sources and critical thinking skills as well as authoring monthly signaling reports
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
• Other duties as assigned by manager
Qualifications and Education
• Healthcare Professional degree required (e.g. RN, PharmD, PA, MD) minimum of one year post-graduate clinical experience.
• Pharmaceutical industry experience desirable in Safety Scientist/PV Risk Management role
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data and developing risk management/mitigation strategies
• Experience in the preparation and authoring of aggregate safety reports, RMPs, and RSI desirable
• Previous experience in oncology therapeutic area, especially with immunotherapeutics, is preferred
• Ability to apply principles, concepts and industry best practices governing pharmacovigilance and risk management in assigned projects.
• Excellent verbal and written communication skills, as well as presentation and team-interaction skills are necessary
• Proficiency in Microsoft Office
• Efficient in time management and multi-tasking
• Strong organizational skills, including the ability to prioritize independently with minimal supervision
Valid through: 12/8/2020
$80K — $100K
7 days ago