Global Head of Safety and Pharmacovigilance

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Job Summary

*Role can based at our Cambridge, MA or Toronto, Ontario locations.  The role can also be remote in the U.S. or Canada.

The Global Head of Drug Safety will be responsible for the strategic implementation, execution, and management of Pharmacovigilance and risk management activities in conjunction with the AVROBIO’s development and future looking commercial activities. They must effectively collaborate cross-functionally at all levels in the organization as well as external safety service providers and regulatory authorities.

The Global Head of Drug Safety will lead and is accountable for providing strategic medical oversight for all pharmacovigilance functions which includes but is not limited to: (1) overseeing and leading the signal assessment and management process in conjunction with the PV team and external vendors (ie CROs) (2) management and mentoring of the drug safety team, (3) product benefit- risk management, (4) oversight of PV Operations within Quality,  Compliance and PV Systems Analytic Team functions for investigational and eventually marketed products; (5) address any external questions related to product safety; and ensure proactive safety signaling and timely risk-benefit assessments of safety data. The candidate will play a visible role towards providing safety leadership and advisement in company wide forums and initiatives.

Research and Development
Key Responsibilities
  • Build-out of the safety management system in preparation for a Global product launch
  • Lead and oversee and direct all aspects of Pharmacovigilance and risk management activities for development products and potential marketed products
  • Acquire a deep understanding of the disease process and assigned products efficacy and safety profile including a working knowledge of other company products in development
  • Actively contributes to oversight of patient safety in all ongoing clinical trials are completed and documented in a timely manner
  • Design, direct, and conduct ongoing safety surveillance of AVROBIOs drug products using internal and external resources (e.g. CROs) to ensure delivery of high-quality Pharmacovigilance services
  • Negotiates contracts, interacts with and supervises the activities of CROs and consultants for Pharmacovigilance services.
  • Provides ongoing updates to the Head Medical/S/PV, Chief Medical Officer and Executive Leadership Team members on the changing risk-benefit profile of our products and competitors’ products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans
  • Provide strategic planning, implementation, and management of drug safety activities to support clinical development of company products and actively contribute to corporate risk management related to drug safety
  • Design, implement and manage Risk Evaluation and Mitigation Strategies (REMS) ensuring that product benefits outweigh possible risks, fulfilling medical information requests globally.
  • Provide oversight of all clinical safety activities including review of medical coding of AEs, con-meds, and processing of SAEs through the entire lifecycle including preparation of analyses of similar events (ASE) for unexpected and related serious adverse events (SUSARs) from clinical trials
  • Lead responses and resolutions to safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
  • Direct the development, preparation and compliance of periodic and annual safety reports (e.g., DSUR), investigator communications, product labeling/package inserts and other reports as necessary that relate to product drug safety
  • Provide medical expert safety review input into all critical documents for clinical development plans of products (e.g., clinical study, protocols and amendments, ICFs, IBs, IMPDs, support DSMB, clinical safety reports, INDs, CTAs)
  • Ensure departmental budgets and schedules meet corporate requirements
  • Manage internal staff and work to establish the permanent Drug Safety Team overseeing both internal employees and external contractors to ensure delivery of quality safety and pharmacovigilance services
  • Monitor industry best practices and changes in global safety regulations and guidelines. Recommends changes and upgrades to existing departmental policies, SOPs and systems to ensure global regulatory compliance
  • Support the Head of Medical/S/PV and provides strategic Medical insights to help the Head Medical/S/PV respond to safety-related questions from external sources including the investment community
  • Coordinate effectively across functions including Clinical, Medical Affairs, Regulatory and Quality effectively to perform the above responsibilities and achieve the expected risk management outcomes
  • Mentoring team towards continuous improvement/enhancement of PV work procedures consistent with good pharmacovigilance practices for regulatory inspection readiness
Minimum Requirements/ Qualifications
  • M.D./PhD/MS/MPH/PharmD or RN is required.
  • Clinical expertise in the rare disease/orphan drug space is preferred. Experience with gene therapy products is optimal but not required.
  • Minimum of 10years of global experience in Drug Safety in a biotechnology required with a preference in the rare disease/orphan drug space
  • Minimum of 5 years as a direct manager within a global PV / Safety functions
  • Deep understanding of risks and risk mitigation steps related to safety signals and pharmacovigilance
  • Expert knowledge of FDA safety regulations, ICH Guidelines, EU GVP and other applicable regulatory guidance documents; expertise in global safety regulations
  • Knowledge of U.S. and International Regulatory Reporting Requirements for Product Safety, and of the clinical development process.
  • Expert knowledge of relational database applications (including ARGUS, ARISg, or other safety database).
  • Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities
  • Demonstrated ability to solve problems with innovative solutions along with strong organizational skills
  • Possess strong and dynamic leadership skills, with excellent written, verbal, and presentation skills
  • Effective team player who fosters collaboration within and across functional areas
  • An accurate understanding and precise focus on the risk management aspects of the safety

AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO, Inc is an EEO employer