Manager, Drug Safety Operations

Company Description
Zymeworks is a publicly listed (NASDAQ:ZYME) R&D and 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. We are a global company headquartered in Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and Redwood City, CA.

Why Work With Us

Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

This role can be located in Redwood City CA, Bellevue WA, or Dublin IRE, and is hybrid with a minimum of 3 days per week onsite.

How You'll Contribute

The Manager, Drug Safety Operations is a global role providing expertise to multiple and/or single but complex products in development within the Oncology therapeutic area. The role holder will be responsible for preparing and oversight of safety documents and deliverables for these projects in collaboration with the Executive Director of Drug Safety. The Manager, Drug Safety Operations will also focus pro-actively safety analysis, risk management of safety risks to patients and management of CROs. The Manager, Drug Safety Operations will collaborate with clinical teams in developing SOPs. You will facilitate collaboration with colleagues from across Zymeworks and externally, including counterparts within Clinical Project Teams and Global Regulatory Affairs.

What You'll Do

• Support Safety strategy for multiple or complex periodic regulatory documents according to the agreed process and timelines
• Establish, review and update department procedures and SOPs
• Assist with negotiations and provide expertise to the drug safety component of contracts/agreements with third parties to ensure quality and integrity of agreements
• A member of the Safety Management Team setting the meeting agenda, producing necessary data outputs, facilitating discussions, and documenting conclusions of any meetings
• 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.); co-ordinates meetings and tracks timelines to ensure completion
• Support responses for regulatory or other ad-hoc safety queries in collaboration with Safety head
• Contribute to 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
• Maintain knowledge of therapeutic area(s) for assigned products
• Identify opportunities for, or the need to, enhance existing processes through knowledge of internal and external environment
• 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 and critical thinking skills as well as authoring monthly signaling reports
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection

What You'll Bring

• Healthcare Professional degree (e.g. RN, PharmD, PA) with minimum of one year post-graduate clinical experience and 5 years of Drug Safety experience preferred.
• Advanced Patient Safety and/or Clinical/Drug Development experience of leading safety &/or scientific activities, across the following areas:
• • Drug Safety Signal detection and mitigation
  • Periodic Safety Reports (preparation and authoring)
  • Risk Management Plans (establish SOPs, preparation and authoring)
• Demonstrated ability to handle more than one complex project simultaneously, prioritizing well and recognizing key issues
• Excellent knowledge of MedDRA coding and WHO Drug coding
• Hands-on experience with adverse event case processing in Argus/Aris-G database
• Pharmaceutical industry experience desirable in Safety Scientist/PV Risk Management role
• Previous experience in oncology therapeutic area, especially with immunotherapeutic or antibody drug conjugates, is necessary
• Ability to work effectively in an advanced matrix structure
• Ability to apply principles, concepts and industry best practices governing pharmacovigilance and risk management in assigned projects.
• Excellent verbal and written communication skills, as well as presentation and team-interaction skills are necessary.
• Proficiency in Microsoft Office.
• Efficient in time management and multi-tasking.
• Strong organizational skills, including the ability to prioritize independently with minimal supervision

Total Rewards

We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.

The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate's location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).

Our total rewards package that includes:

• Industry leading vacation and paid time off
• Exceptional medical, dental and vision benefits by country
• Zymelife health and wellness benefits
• Matching RRSP / 401K / Pension program
• Employee Share Purchase Program
• Employee Equity Program
• Paid time off to volunteer in your community

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.

NOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.

The pay range for this role is:

116,250 - 178,250 USD per year (US)