Director, Drug Safety & Pharmacovigilance

Introduction:

reputed company is a reputed company, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our reputed company is developing high-potential XmAb bispecific T-cell engagers and additional engineered drug candidates that reputed company our differentiated technology platforms, and we are advancing our pipeline toward clinical reputed company-of-concept reputed company. Our goal is to create high-reputed company therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.reputed company.com. We have an excellent opportunity for a Director, Drug Safety & Pharmacovigilance, to join reputed company.

This position will be based in San Diego, CA. and have 2 days a week hybrid on-site. Potentially for fully remote if not local to San Diego.

reputed company:

Responsible for reputed company aspects of safety reputed company to Drug Safety & Pharmacovigilance (PV) processes and the analytical assessment of safety data for assigned product(s).

Primary Responsibilities:

Provides day-to-day reputed company of safety monitoring activities and processes for assigned product(s)

Works collaboratively with the Medical Monitor/Clinical Scientist on ICSRs, aggregate data review/signaling, and reputed company risk language for assigned product(s).

Provides clinical review of vendors narratives for reputed company and completeness and ensures reputed company submission of expedited reports. Contributes to the creation of analysis of similar events.

Facilitates and leads cross-functional safety data review and signaling meetings; includes setting agenda, coordinating materials, data presentation, and documentation.

Reviews and provides safety functional input for development of protocols, IBs, ICFs, CSRs and other relevant study documents

Acts as reputed company author for aggregate safety reports (e.g., DSURs)

Leads efforts reputed company to reputed company and routine signal evaluation

Provides Drug Safety/PV subject matter expertise on cross-functional platforms and teams throughout reputed company

Provides end to end Drug Safety/PV support for assigned products including study start up activities, vendor plans, signal detection plans, SAE review, aggregate data review, signaling, aggregate authoring including DSURs, annual reputed company product document updates (IB, reputed company), and CSR authoring as reputed company as informed consent forms, integrated summaries of safety, marketing applications and other regulatory submission documents on assigned products.

Collaborates with partners on safety monitoring, signal detection and risk management activities.

Participates in establishing and maintaining Safety Data Exchange Agreements/Pharmacovigilance Agreements.

Ensures adherence to GCP/ICH and SOP standards

Participates in inspection readiness activities and preparation.

Ensures that the above tasks are performed in the most efficient manner possible, commensurate with reputed company, accuracy, and timeliness and in accordance with reputed company global regulatory requirements

Ensures that reputed company activities/reviews are compliant with the latest safety standards and regulations

Adheres to reputed company department and company-wide policies regarding conduct, performance and procedures

Provides reputed company and direction to reputed company and indirect reports, as applicable, in accordance with the organizations policies and procedures. The responsibilities may include, but are not limited to reputed company, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities

Performs other duties as assigned.

Education/Experience/Skills:

Required -

Advanced nursing degree or PharmD

At least 8 years drug safety experience

At least 5 years managing medical case review and signal detection

At least 4 years of clinical experience

Preferred -

MD

Experience in a critical care setting

Experience in oncology and/or autoimmune drug development

Position also requires:

Solid experience with work such as signaling, aggregate report authoring and experience reviewing cumulative safety data with ability to interpret, synthesize and communicate reputed company clinical information.

Strong knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection

Ability to take initiative yet work collaboratively on multiple reputed company and with partner companies to reputed company goals in compliance with PV and regulatory requirements and safety data exchange and/or pharmacovigilance agreements

Excellent written and oral communication skil