Head of Safety and Pharmacovigilance

The Role:

Embark on a journey of innovation and profound impact with us as we chart new territories in the biopharmaceutical landscape. If you are a forward-thinking professional seeking to leave a lasting mark, we warmly invite you to join our dynamic and driven team. Agenus Patient Safety and Pharmacovigilance is seeking an experienced and collaborative team member to support the Patient Safety and Pharmacovigilance department’s operational and compliance capabilities in support of the clinical pipeline. This candidate must be able to work cross-functionally, and independently to ensure Agenus adhere to global regulations pertaining to vendor oversight, case management, ICSR submissions, inspection readiness, and safety data exchange agreement commitments.

In the role you will:

Establish and maintain oversight of safety vendor(s) day-to-day case processing activities, global ICSR submissions, case quality, KPIs, SAE reconciliations and study configurations in the global safety database.

Expertise to review and define the safety strategy for the BLA filings including, review of phase 3 protocol, review of ISS TLFs, review SCS and support CSR narrative template development or CSR narrative review

Author SOPs, WIs, and corporate policies pertaining to Safety and Pharmacovigilance Operations and Compliance tasks to ensure global compliance with Health Authority regulations.

Provide support in periodic review of aggregate safety data for potential trends or signals in a timely manner.

Perform signal detection activities and analysis to support evaluation and characterization of safety topics.

Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and support strategies for safety assessment in collaboration with executive leadership.

Responsible for authoring, reviewing, and commenting on Safety Data Exchange Agreements/Pharmacovigilance Agreements with business partners.

Create, and maintain a safety quality management system and ensure a state of constant inspection readiness.

Collaborates with key internal and external stakeholders to provide safety expertise and guidance for interdepartmental and cross-functional team deliverables.

Work cross-functionally to author, as appropriate, responses to health authority queries.

Responsible for hiring and providing managerial support to direct reports with overall responsibility of leading, training and mentoring for effective performance.

Collaborate with Clinical Quality to establish Safety and Pharmacovigilance training programs for the Patient Safety and Pharmacovigilance department.

Serve as the Safety lead for audits and inspections. Responsible for identifying and following-up on corrective action plans and remediations.

Qualifications: About You

Healthcare professional degree required (PharmD, RPh, NP, RN, BSN, PA, MD).

Minimum of 10-15 years’ experience in Pharmacovigilance, with 6+ years in Operations and Compliance.

Ability to identify and establish best practices for continuous improvement of case quality, compliance, and improvement.

Thorough knowledge of FDA, EMA, ICH guidelines and other global regulations.

Excellent interpersonal, communication, analytical and organizational skills with proven success in leading and collaborating with cross-functional teams.

Oncology experience is preferred.

Strong knowledge and experience with available Safety and Pharmacovigilance databases, and other infrastructure tools to assist in quality and compliance of ICSRs.

Ability to thrive in a fast-paced environment.

Sound strategic evaluation, analysis and decision-making skills.

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