Manager, Global Patient Safety Systems

Pharmacovigilance & Safety United States


Description

Why Work for Us?

Innovation. Act with Integrity. Collaboration. Embrace Diversity. 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.

Company Description

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 Manager, Global Patient Safety Systems who is looking to grow their career with our company. The Manager, GPS Safety Systems will assist in providing expertise, leadership, and collaboration for internal and external customers, to ensure overall Global Patient Safety excellence. This individual will oversee the processing and submission of Individual Case Safety Reports (ICSR) generation of aggregate safety reports, safety analyses, signal detection, and respond to time-sensitive, ad hoc requests from internal and external stakeholders.

This position will report to the Director, Pharmacovigilance Safety Systems and will be located remote within the US.

Job Description and Responsibilities

  • Manage the proper function, maintenance, and validation of Zymeworks’ Safety systems (Argus Safety System and other supporting systems) and adherence to our policies and applicable global (PV) regulations.
  • Act as liaison to vendor team on implementing Safety system configuration changes and system upgrades.
  • Oversee signal detection vendor and collaborate with Safety Science to ensure all signal management activities meet regulatory and compliance standards.
  • Lead the development of GPS agreements with license partners and/or other parties as required.
  • Prepare and maintain Global Patient Safety departmental policies and SOPs that address GPS systems, alliance management, signal management, and training activities.
  • Lead and maintain oversight on GPS documentation and record retention for department.
  • Lead the development and maintenance GPS Master File.
  • Support IND, BLA and MAA regulatory submissions from GPS perspective.
  • Develop, validate, and maintain required aggregate safety reports.
  • Administer the generation of ad hoc safety outputs/reports based on business need.
  • Partner with Business Partners and Regulatory Authorities to set up automated safety data exchange using Electronic Gateways.
  • Present timely flow of business intelligence information to users.
  • Proactively communicate information and project status to stakeholders
  • Be the technical subject matter expert for Safety system and lead projects as needed
  • Resolve issues with Argus Safety System by researching and troubleshooting system issues.
  • Facilitate the selection and implementation of additional Drug Safety informatics systems, including signal detection and surveillance tools, safety data warehouse and reporting systems.
  • Support routine dictionary upgrades.
  • Assist with internal and external audits of the Argus Safety System.
  • Provide guidance and support for interdepartmental and/or corporate initiatives. 

Qualifications

  • A bachelor’s degree in information systems or related field with at least 7 years of IT experience.
  • A minimum of 5 years of experience with Drug Safety Systems Support in a biotech/pharmaceutical or CRO industry required
  • Extensive drug safety experience and solid knowledge of drug development required
  • Expert knowledge of global Drug Safety requirements, e.g., US Code of Federal (CFR) regulations, European Union (EU) Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines
  • Experience and extensive working knowledge of proprietary safety databases; experience with Argus strongly preferred
  • Experience managing business process outsourcing vendors and relationships; Drug Safety processes for individual cases and medical review; aggregate data assembly and clinical study safety management
  • Experience and extensive working knowledge of signal detection and evaluation, review, working with license partner and Drug Safety agreement.
  • Ability to write advanced SQL query. Experience with reporting platforms and data visualization tools (e.g., OBIEE, Cognos, Spotfire) preferred.
  • Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing.
  • Strong relationship building skills with ability to interact effectively in a multifunctional, multicultural, growing organization.
  • Strategic thinking, strong organizational and analytic skills, project management, excellent
  • Excellent organizational skills, consistent attention to detail, and project management expertise.
  • A demonstrated ability to prioritize, plan, and organize priorities and work under strict timelines is required.
  • An equivalent combination of education and experience may be considered.
  • Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.

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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