Client:
Zymeworks
Location:
Dublin, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
8236d4f8f987
Job Views:
7
Posted:
24.06.2025
Expiry Date:
08.08.2025
Job Description:
Key Responsibilities
* Provide leadership, strategic direction, and governance of patient safety and pharmacovigilance activities across our portfolio.
* Model and promote adherence to Zymeworks values and mission.
* Coach and mentor staff, including direct reports, ensuring accountability.
* Support department policies and procedures for Drug Safety Operations.
* Manage resources to meet approval timelines and development goals, including workforce planning and budget management.
* Oversee medical review of serious adverse event reports for accuracy, integrity, and medical coding consistency.
* Identify and communicate safety signals promptly, overseeing signal detection tools and sources.
* Evaluate the safety profile of investigational products, collaborating with medical monitors and reporting potential safety issues.
* Support cross-functional teams on safety-related matters.
* Review responses to regulatory agency questions concerning drug safety/pharmacovigilance.
* Assist in safety sections of clinical documents such as protocols, reports, and INDs.
* Assess PV resources, equipment, and systems for efficiency.
* Support development and maintenance of the product benefit-risk profile.
* Collaborate on business development strategies.
Education and Experience
* MD required; experience in oncology, autoimmune, or inflammatory diseases preferred.
* Experience in pharmacovigilance and regulatory filings within biotech or pharma industries.
* Regional experience in at least two of the following: EMEA, APAC, North America.
Skills and Abilities
* 6+ years' industry experience, including leading multidisciplinary teams.
* Strong leadership combining pharmacovigilance expertise with strategic management skills.
* Experience with medical safety activities, operations, and risk management in both pre- and post-marketing.
* Knowledge of FDA, EU, ICH guidelines for safety reporting and clinical trial safety processing.
* Proficiency with MedDRA and safety databases (e.g., Aris, AERS, Argus).
* Ability to interpret and evaluate adverse event reports for submissions.
* Excellent clinical judgment and communication skills.
* Experience working with management and stakeholders, influencing outcomes.
* Entrepreneurial or high-growth company experience preferred.
* Attention to detail, ability to work independently and in teams, with external partners.
* Excellent written and verbal communication skills.
Total Rewards
We offer a competitive package including salaries, benefits, and professional growth opportunities. Our team enjoys:
* Industry-leading vacation and paid time off
* Comprehensive health and wellness benefits
* Zymelife wellness program
* Paid community volunteering days
* Matching pension savings
* Employee Share Purchase and Equity Programs
We are an equal opportunity employer. If you are not a passport holder of the country of the vacancy, a work permit may be required. For more info, check our Blog. Applications should be submitted via the 'Apply now' button. Do not include bank or payment details in your application.
#J-18808-Ljbffr