Director, Safety Operations, Pharmacovigilance

Director, Safety Operations, Pharmacovigilance

Company Name: Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!

Position Summary

The Director, Safety Operations, Pharmacovigilance is responsible for implementing and coordinating the PV department procedures, providing strategic direction and oversight of operations ensuring compliance with global PV regulations. This position represents the Pharmacovigilance department internally and externally at a global level. He/She supports all PV operations including but not limited to vendor selection process, vendor management, inspection readiness, KPIs and CAPAs related to PV operations, case processing metrics, SOP development and revision, and internal processes that support cross-functional PV initiatives.

Responsibilities

• Lead effective vendor management strategies for PV.
• Ensure PV department inspection ready.
• Responsible for PV functional service provider (FSP) strategy and managing the selection process.
• Responsible for developing a PV database strategy.
• Provide Pharmacovigilance Operational support to clinical trial study teams and commercial products.
• Serve as a subject matter expert for internal audits and global regulatory inspections.
• Serves as key point of contact between PV and the CROs regarding PV operation management.
• Communicates regularly with CROs and develops quality ICSR case processing and reporting metrics.
• In conjunction with the compliance team, supports the escalation and investigation of safety and non-compliance issues and identifies root causes for late ICSR submissions and the implementation of appropriate corrective actions, as needed.
• Develops PV training plans and competency assessments for PV department.
• Contributes to the development and maintenance of Safety Management Plans (SMPs).
• Provides oversight and direction to direct report(s).

Qualifications

• Bachelors degree in scientific related field preferred or combination education/experience.
• 10+ years of PV experience in the pharmaceutical/biotech industry.
• Clinical trial product support and commercial product support experience preferred.
• Proven track record of leadership and operational excellence.
• Ability to help shape key department goals and objectives, drive process and operational efficiencies, and contribute to ongoing development of innovative best practices both internally and with other cross-functional groups.
• Able to work independently, establish work priorities, and execute decisions with minimal guidance.
• Experienced in global regulatory requirements for pharmacovigilance.
• Direct experience participating in regulatory authority inspections.

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $178,400 to $223,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.

Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.