Director, Drug Safety/Pharmacovigilance Operations

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Director, Drug Safety/Pharmacovigilance Operations

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

The Director, Drug Safety /PV Operations will lead and is accountable for providing oversight for pharmacovigilance functions which includes but is not limited to: (1) overseeing and facilitating the signal assessment and management process in conjunction with the PV team and external vendors including CROs and scientific consultants (2) management and mentoring of the drug safety operations team- as this team is built in the future (3) product benefit- risk management, (4) oversight of PV Operations and PV Systems Analytic Team functions for investigational and eventually marketed products; (5) ensure proactive safety signaling and timely risk-benefit assessments of safety data. The candidate will play a visible role towards providing safety operations leadership and advisement in trial program and platform initiatives.

The position will report directly into the SVP, Head of Medical and Drug Safety.

Feb 25 2021
Key Responsibilities
  • Build-out of the safety management system to support the overall platform and portfolio in preparation for supporting larger scale pivotal studies as well as Global product launches in the future.
  • 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 contribute 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
  • Assist in the design, implement and manage Risk Evaluation and Mitigation Strategies (REMS) where indicated in order to assure 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
  • Support responses and resolutions to safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
  • Track and assist in 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 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 7 years of global experience in Drug Safety operations, a substantial portion of which should include experience within a biotechnology oriented company required with a preference in the rare disease/orphan drug space
  • Minimum of 3 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