Executive Director, Pharmacovigilance

Zymeworks; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

A leading company in the biotech sector seeks a strategic leader for patient safety and pharmacovigilance. Ideal candidates should have an MD with experience in oncology and a proven track record of managing multidisciplinary teams. A competitive compensation package and growth opportunities are offered.

Benefits

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

Qualifications

• 6+ years' industry experience in pharmacovigilance.
• Experience in oncology preferred.
• Knowledge of FDA, EU, ICH guidelines.

Responsibilities

• Provide leadership and strategic direction for pharmacovigilance activities.
• Manage resources and oversee medical review of adverse event reports.
• Support cross-functional teams on safety-related matters.

Skills

Leadership

Pharmacovigilance expertise

Strategic management

Communication

Clinical judgment

Attention to detail

Education

MD

Tools

MedDRA

Aris

AERS

Argus

Job description

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.