Drug Safety Specialist

Pharmacovigilance & Safety United States


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 professional who is looking to grow their career with our company.

This position will report to the Senior Manager, Drug Safety Operations and will be based in Vancouver, BC/Seattle, WA or Remote.

 Key Responsibilities

  • Preparation of complete, accurate and concise safety reports, including expedited safety reports, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs)
  • Review serious adverse event (SAE) information received for completeness and consistency, initiates case follow-up activities/SAE query management
  • Perform triage of SAE information including clinical assessment of reports, expectedness and relatedness assessments, confirmation of regulatory reporting requirements
  • Perform data entry of case specific information and writing of concise safety narratives in the drug safety database
  • Performs quality control activities to ensure complete and accurate case information has been entered into the drug safety database
  • Assist with case intake and submission activities, as needed
  • Participate in SAE reconciliation, coding reviews and other study team activities
  • Support inspections and audits as needed

Qualifications and Experience

  • Minimum of a Bachelor's Degree In Pharmacy, Nursing, Physician Assistant or other health-related field
  • At minimum of 1 year of Drug Safety case processing experience in the biopharmaceutical industry setting
  • Working knowledge of relevant FDA regulations and ICH guidelines governing clinical trials.
  • Must have strong clinical judgement and analytical skills.
  • Experience with Argus preferred, experience with a validated safety database required
  • Experience with MedDRA and WHODrug coding
  • Excellent oral and written communication skills
  • Proficiency In standard desktop software programs (Word, Excel, Outlook)
  • Excellent Interpersonal skills and ability to work effectively cross-culturally and cross-functionally
  • Must be quality oriented and demonstrate consistent attention to detail
  • 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.

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. 

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.