Director, Drug Safety Operations

Job type: Full-Time
Accepting BioReady™: Yes
Category: Regulatory Affairs
Education: Master
Employer: Zymeworks Inc.
Salary:
Location: Seattle, WA
Posted: September 14, 2020
Closes: October 14, 2020

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.

This position will report to the Vice President, Global Patient Safety and will be based in Seattle WA or remote. 

Key Responsibilities: 

The sponsor continues to monitor for IRR incidence and severity.

  • Expert in Pharmacovigilance and GCP/ICH compliance regulations and guidelines, as well as in applicable and/ or applicable partner SOPs.
  • Management of workload and resources for global operations team to meet global regulatory timelines.
  • Coordinate and chair regular team meetings.
  • Provide strategic management and policy proposals for the Operations team.
  • Ensure consistency of work practices across teams both locally and globally.
  • Ensures corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development programs. 
  • Collaborates with partners on the development of Pharmacovigilance Agreements and the exchange of safety data, safety monitoring, and the safety profile of investigational drugs as defined in those agreements. 
  • Provides guidance and support to project teams for safety-related areas, including protocol development and study conduct. 
  • Trains staff on drug safety principles and procedures. 
  • Manages and mentors staff and assigns responsibilities as appropriate to meet timelines and quality metrics. 
  • Ensures alignment among case handling, aggregate reporting, and signal detection activities. 
  • Manages the budget and resources for the Global Patient Safety Operations function.

Education and Experience:

Healthcare professional degree required (e.g. RN, PharmD, RN, PA) and clinical experience desired.  Minimum of 5 years’ pharmaceutical industry drug safety experience (with a minimum of 3 years of functional management experience overseeing PV staff).

Skills and Abilities:

Knowledge of and experience with international regulatory adverse event reporting requirements. 

  • Demonstrated line management experience. 
  • Hands-on experience with adverse event case processing in Argus/Aris-G database. 
  • Proven experience and effectiveness at training and mentoring drug safety staff. 
  • Proven experience with business alliance building.
  • Proven experience with inspection readiness in US and rest of world.
  • Excellent knowledge of MedDRA coding and WHO Drug coding. 
  • Ability to work independently, establish functional priorities and execute on goals. 
  • This position demands excellent interpersonal communication skills, decision-making and ability to adapt to a dynamic and complex regulatory and business environment.

Experience in oncology drug development desired. 

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://zymeworks.bamboohr.com/jobs/view.php?id=362. 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 any fees related to resumes that are unsolicited or are received without contract. 

 

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