Associate Director, Safety Ops

Denali Therapeutics Inc; Zürich; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

Pension

Medical stipend

Equity

Broad range of other benefits

Zusammenfassung

Denali Therapeutics Inc in Zürich, Switzerland is looking for an experienced individual to lead global pharmacovigilance operations. The role involves overseeing safety case management, vendor management, and ensuring compliance across clinical and post-marketing programs.

The ideal candidate should possess a Bachelor’s degree along with at least 12 years of experience in pharmacovigilance, demonstrating expertise in regulations and strong leadership skills. A competitive benefits package will be provided.

Qualifikationen

• Typically requires 12+ years of relevant experience in pharmacovigilance.
• Demonstrated expertise in global pharmacovigilance regulations (FDA, EMA, ICH).
• Proven ability to lead complex, cross-functional initiatives.

Aufgaben

• Oversee global pharmacovigilance operations for assigned clinical programs.
• Ensure compliant safety case intake, processing, reporting, and reconciliation.
• Manage pharmacovigilance vendors and external partners.

Kenntnisse

Global pharmacovigilance regulations

Vendor management

Leadership

Problem-solving

Communication

Ausbildung

Bachelor's degree

Jobbeschreibung

Leads the execution and continuous improvement of global pharmacovigilance operations to ensure compliant, efficient, and high-quality safety data management across clinical and post-marketing programs. Drives cross-functional coordination and vendor oversight to support timely adverse event reporting, inspection readiness, and regulatory compliance. Contributes to the enhancement of pharmacovigilance processes and systems to support program advancement and global expansion.

Key Accountabilities / Core Job Responsibilities

• Oversee global pharmacovigilance operations for assigned clinical programs
• Ensure compliant safety case intake, processing, reporting, and reconciliation across all sources (including clinical studies and post-marketing sources)
• Oversee safety case management activities to ensure adherence to global regulatory requirements, company procedures, and reporting timelines
• Manage pharmacovigilance vendors and external partners, ensuring performance, compliance, and alignment with contractual and operational expectations
• Lead the development and oversight of safety data exchange agreements (SDEA) / PV Agreements (PVA) with license partners and/or other parties
• Drive continuous improvement of pharmacovigilance processes, systems, and workflows to enhance efficiency and quality
• Lead the planning and operational delivery of aggregate safety reports (e.g., DSUR, PBRER, PADER)
• Partner cross-functionally with Clinical, Regulatory, Safety Science, and other stakeholders to ensure effective adverse event handling and communication
• Monitor pharmacovigilance compliance metrics (KPIs/KQIs), identify trends, and implement corrective and preventive actions as needed
• Support regulatory inspections, audits, and inspection readiness activities, including documentation and response preparation
• Contribute to the development and maintenance of pharmacovigilance procedures and training to ensure organizational awareness and compliance
• Support safety-related inputs into clinical and regulatory documents (e.g., protocols, Safety Management Plans, MA submissions)
• Support the implementation of safety procedures related to the company international market expansion efforts

Qualifications / Skills

• Typically requires a Bachelor’s degree and 12+ years of relevant experience, or an equivalent combination of education and experience, with strong focus on pharmacovigilance safety operations in a global environment
• Demonstrated expertise in global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH)
• Experience managing vendors and external partners supporting pharmacovigilance activities
• Proven ability to independently lead complex, cross-functional initiatives and manage multiple priorities
• Experience supporting regulatory inspections and audits within a pharmacovigilance system
• Strong communication, organizational, and problem-solving skills with ability to operate effectively in a fast-paced, matrixed environment
• Experience in both pre-approval and post-marketing pharmacovigilance activities

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience.

Denali offers a competitive total rewards package, which includes a pension, medical stipend, equity and a broad range of other benefits.

We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.