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AlloVir - Senior Director, Pharmacovigilance and Safety Operations

Company: ElevateBio
Location: Cambridge
Posted on: September 16, 2020

Job Description:

AlloVir - Senior Director, Pharmacovigilance and Safety Operations Title: Senior Director, Pharmacovigilance and Safety Operations - AlloVir

Location: Cambridge, MA

Reports to: Head of Drug Safety

The Role

At AlloVir (formerly ViraCyte) it is our mission to develop and deliver transformative cell therapies for patients suffering from life-threatening virus-associated diseases. We are the leader in the clinical development of novel cell therapies designed to restore natural T-cell immunity against devastating virus-associated diseases in immunocompromised patients, including stem cell and organ transplant recipients. AlloVir has built an innovative technology platform developed by researchers at Baylor College of Medicine’s Center for Cell and Gene Therapy. Our proprietary technology platform delivers commercially scalable, “ready-to-administer” solutions by leveraging off-the-shelf, allogeneic, multi-virus specific T-cells, designed to treat or prevent multiple devastating virus-associated diseases. We are now planning and advancing mid- and late-stage clinical trials across our growing product pipeline.

AlloVir is seeking a Senior Director of Pharmacovigilance and Safety Operations . This person will be responsible for creating, directing, and managing the company’s infrastructure to support the operational aspects of the pharmacovigilance system and adheres to all global safety requirements and internal processes and procedures. He/She will have experience in and perform multiple activities related to our case management, data review and assessment, document development and review including procedures for the accurate and timely processing, review, and reporting across the portfolio. In addition, this position will build and maintain sustained and trusting relationships with key strategic internal and external stakeholders, including leadership for interactions with health authorities, support review and development of regulatory submissions and PV activities.

RESPONSIBILITIES

Establish and maintain successful working relationships with and provide oversight to PV Vendors/CROs with day-to-day PV operational activities for investigational products including but not limited to ICSR activities and aggregate reports.

Oversee and maintain writing/review of Pharmacovigilance Agreements

Responsible for implementing PV related activities within the scope of PV operations as outlined in relevant agreements with Business Partners and/or other parties, as required.

Ensure overall performance of the department and compliance with global regulatory requirements by assisting in implementation of applicable SOPs, processes, metrics, and monitoring of performance and compliance.

Responsible for compliant and quality execution of all operational activities related to case management and related activities.

Oversee timely submissions of expedited safety reports to the FDA, EMA & other health authorities

Collaborates with key internal and external stakeholders to provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards and metrics

Liaises with financial/project management for budget planning

Provide Subject Matter expertise (SME) during audits and inspections in the areas of case processing/case management activities, literature monitoring, metrics, vendor oversight

QUALIFICATIONS

REQUIRED

Degree in Life Sciences or related discipline required

Minimum 5 years recent experience in PV Operations, with relevant scientific/clinical, or pharmaceutical experience

Working knowledge global pharmacovigilance regulations

Experience with safety database systems

Demonstrated ability to develop, execute and follow-through complex projects to completion

Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

Independently motivated, detail oriented and strong problem-solving ability

Strong leader, and team player who demonstrates initiative, willingness to roll-up his/her sleeves, and problem solve

Ability to thrive in a fast-paced environment

Strong writing skills is a must, including experience in the preparation and authoring of individual safety reports

Ability to communicate effectively and represent the Regulatory and Safety organization

PREFERRED

Advanced degree preferred (Masters, PharmD, MD, PhD)

Cell and gene therapy experience

Join the leader in the development of novel cell therapies with a focus on restoring natural immunity against life-threatening virus-associated diseases in patients with severely weakened immune systems. Over many years, AlloVir’s world-leading scientists have developed a highly innovative pipeline of allogeneic, off-the-shelf, T-cell therapies being studied to treat and prevent many devastating and life-threatening virus-associated diseases. The company’s lead product, Viralym-M, an investigational cell therapy to treat active virus-associated diseases, including from BK hemorrhagic cystitis, cytomegalovirus, adenovirus, Epstein-Barr virus, JC virus and human herpesvirus 6. AlloVir’s technology and manufacturing process enables the potential for the treatment and/or prevention of up to six devastating viruses with each single allogeneic cell therapy.

Join AlloVir to help advance the development of this innovative technology platform and multiple mid- and late-stage clinical trials to help severely immunocompromised patients. AlloVir is part of the ElevateBio-family of companies with access to ElevateBio BaseCamp’s industry-leading, centralized cell and gene therapy manufacturing capabilities. By joining AlloVir, you will be able to not only advance innovative science but also a part of a truly new business model for advancing cell and gene therapies.

AlloVir is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic

AlloVir is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. AlloVir will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Keywords: ElevateBio, Cambridge , AlloVir - Senior Director, Pharmacovigilance and Safety Operations, Other , Cambridge, Massachusetts

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