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.
Zymeworks 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.
- Lead 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
- Lead 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 timelines
- Lead and/or manage in the Safety Management Team (SMT) including setting agenda, producing necessary data outputs, facilitating discussions, and documenting conclusions
- Lead 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 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), 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 issues
- Lead 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 documents
- Perform 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 products
- 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 using critical thinking skills and communicate complex clinical information and safety data to healthcare professionals (HCPs) and non-HCPs.
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
- Provides input to Pharmacovigilance policies and standard operating procedures.
- Other duties as assigned by manager
Qualifications and Experience
- Healthcare Professional degree (e.g. RN, PharmD, PA, MD) with minimum of 10 years of Pharmacovigilance experience required; with previous signal detection/safety surveillance and international experience preferred.
- A minimum 1 year medical/clinical experience post-graduate training
- 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
- Previous experience in oncology therapeutic area, especially with immunotherapeutics, is preferred
- Previous work experience with a pharmaceutical company strongly preferred
- Ability to apply principles, concepts and industry best practices governing pharmacovigilance and risk management in assigned projects.
- Strong verbal and written communication skills, as well as highly effective presentation and team-interaction skills are necessary
- Proficiency in Microsoft Office; Argus experience is a plus
- Efficient in time management and multi-tasking
- Strong organizational skills, including the ability to prioritize independently with minimal supervision
- An equivalent combination of education and experience may be considered.
- Embody and champion Zymeworks’ values: Act with Integrity. Collaborate. Care.
- Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.
- Lead and develop team of clinical professionals.
Why Work for Us?
At Zymeworks, we stand for innovation, integrity, collaboration and care.
Zymeworks’ employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at https://zymeworks.bamboohr.com/jobs/.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
How to Apply
If you are interested in this challenging opportunity, please apply online at https://jobs.jobvite.com/zymeworkscareers/job/oxaGefwl. Due to the high volume of applicants, only those selected for interviews will be contacted.
NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for an