Director, Patient Safety & Pharmacovigilance

Job Title: Director, Patient Safety & Pharmacovigilance

Job Number: 84846

Location: Remote, US

Job Description

The Director, PV Science will act as the safety expert responsible for overseeing the global safety strategy and safety profile of assigned products throughout their lifecycle. This role provides both strategic and operational support for safety science in collaboration with various teams working on developmental products. The position requires effective collaboration in a matrix environment with internal departments and external stakeholders, such as investigators and regulatory bodies. This role reports to the Senior Director, PV Science.

Responsibilities

* Oversee daily safety monitoring activities and data for assigned products. * Review and summarize individual case reports and aggregate safety data. * Provide safety and pharmacovigilance expertise to program and study teams, as well as cross-functional teams across the organization. * Organize and facilitate safety review meetings, including preparing materials, presenting data, and managing outputs and agenda. * Review and provide input on clinical documents such as protocols, IBs, ICFs, and CSRs. * Author aggregate safety reports (e.g., DSURs, PSURs). * Contribute expertise for regulatory submissions and responses. * Support the development of core pharmacovigilance processes and capabilities within the department.

Required Skills

* Degree in a healthcare-related field or equivalent, with experience in pharmacovigilance. * 8+ years in the pharmaceutical industry, including at least 5 years in pharmacovigilance. * Experience reviewing and interpreting safety data, with the ability to communicate complex information; oncology experience preferred. * Skilled in preparing and authoring aggregate safety reports. * Strong understanding of the drug development process and safety surveillance. * Capable of completing tasks with thorough documentation. * Effective in collaborative team settings, incorporating various perspectives. * Self-motivated and detail-oriented, with strong problem-solving abilities. * Excellent organizational skills for managing multiple tasks in a fast-paced environment. * Strong communication skills, both oral and written. * Ability to work and influence cross-functionally. * Knowledgeable in GCP and GVP regulations.This role is available at the designated office location, with flexibility for remote work as an option. The anticipated salary range for fully qualified candidates is $235,000 – $250,000, with potential variations based on local market data for remote positions. Factors influencing the actual salary include relevant experience, education, and length of industry experience. In addition to a competitive salary, the position includes opportunities for stock programs, a performance-based bonus, and a comprehensive benefits package. Additional details about the total rewards program are available upon request.

Application Deadline: 2024-11-04