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
Reporting to the Sr. Manager, Drug Safety, the Specialist/Sr. Safety Specialist, Drug Safety has the primary responsibility for the preparation of complete and concise safety reports, including expedited safety reports.
This individual may also support other safety related activities such as receipt and reconciliation of business partner cases, development of study specific safety documents (i.e. SAE report form, completion guidelines), AE/SAE reconciliation, coding reviews, or vendor oversight.
Roles and Responsibilities
- Initial capture of all event-related information
- Initiate urgent queries to sites to obtain event/case information in order to determine reportability
- Perform initial triage of SAEs including assessment of drug-relatedness and expectedness
- MedDRA and WHODrug coding
- Data entry of case specific information in the drug safety database, and writing of concise safety narratives
- Manage the completion, routing and approval of assigned SAE reports to meet business partner and/or regulatory reporting timelines.
- Confirm accuracy of report distribution to pertinent regulatory agencies, clinical sites, and business partners, in conjunction with Regulatory Affairs
- Conduct follow-up with clinical sites to obtain all pertinent adverse event information
- Review and contribute to Drug Safety Operations SOPs, Work Instructions and job aids.
- May train or mentor junior staff
- May represent Drug Safety at study team meetings or other meeting venues
- Contribute to the preparation and review of periodic reports (e.g. DSUR)
- Assist with Risk Management activities as needed
- Other duties may be assigned.
Qualifications and Experience
- Bachelor’s Degree (Pharmacy or RN with critical care management background), PharmD, Physician Assistant, MD, or equivalent required.
- Must have excellent, concise writing skills, and attention to detail.
- At minimum, 2-5 years relevant drug safety/pharmacovigilance experience in the biopharmaceutical industry setting, or equivalent. Oncology experience preferred. Experience with post-market requirements a plus
- Working knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing clinical trials. Knowledge of post-marketing safety requirements is a plus.
- Robust knowledge of MedDRA for adverse event coding, and WHODrug for medication coding.
- Ability to interpret patient health and medical records such as an admit note, discharge summary, etc.
- Ability to manage and prioritize multiple activities and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure.
- Strong analytical, assessment and problem-solving skills.
- Demonstrated ability to read, analyze and interpret clinical data and information.
- Proficiency in use of Excel, Word, PowerPoint
- Excellent interpersonal skills & ability to work effectively cross culturally and cross functionally.
- Prior experience with business partners a plus.
- Excellent written and spoken English.
- Argus safety database experience preferred
Why Work for Us?
Innovation. Act with Integrity. Collaboration. Care
We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
To learn more about Zymeworks Inc. and our current openings, please visit our website at https://zymeworks.bamboohr.com/jobs/.
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 any fees related to resumes that are unsolicited or are received without contract.