• Director, Pharmacovigilance

    Job Locations US-MA-Watertown
    Posted Date 2 months ago(3/7/2018 4:38 PM)
    Job ID
    2018-1088
    # of Openings
    1
    Category
    Regulatory Affairs
  • Overview

    The Pharmacovigilance Director will be responsible for the strategic global implementation, execution, and management of Pharmacovigilance and risk management activities in conjunction with the Company’s development and commercial activities, industry standards, and compliance with global regulations. He/She will collaborate cross-functionally at all levels in the organization as well as external regulatory authorities. The Director will lead and provide oversight for pharmacovigilance, drug safety and risk management for investigational and marketed products, ensuring proactive and timely risk-benefit assessments of safety data.

    Responsibilities

    • Oversees and directs all aspects of pharmacovigilance and risk management activities for investigational compounds and marketed products; actively participates in oversight of patient safety in all clinical trials
    • Designs, directs and conducts ongoing safety surveillance of company drug products using internal and external resources (CROs) to ensure delivery of high-quality pharmacovigilance services
    • Negotiates contracts, interacts and supervises the activities of CROs and consultants for pharmacovigilance services. Provides ongoing updates to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans
    • Provides strategic planning, implementation, and management of drug safety activities to support clinical development of company products
    • Provides 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 role to respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans
    • Directs the development, preparation and compliance of periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings, NDA safety updates, etc...), investigator communications, product labeling/package inserts and other reports as necessary
    • Provides medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs)
    • Manage internal staff and external contractors to ensure delivery of quality safety and pharmacovigilance services, including selecting, developing, training, and evaluating team to ensure the efficient operation of the drug safety function
    • Monitors 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

    Qualifications

    • Familiarity with cGMPs a must
    • Clinical expertise in infectious disease preferred
    • Minimum of 10+ years of progressive experience in Drug Safety in a biotechnology or pharmaceutical company
    • 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
    • Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities
    • Effective team player, fosters collaboration within and across functional areas
    • Minimum BS degree in a scientific discipline (e.g., biology, chemistry, engineering, etc.)
    • Experience with electronic document management and quality systems
    • Experience working with CMOs and contract laboratories
    • Experience in relevant acute care therapeutic areas (e.g. infectious diseases, critical care)
    • Experience with new product launches

    Tetraphase Pharmaceuticals is an Equal Opportunity Employer/Females/Minorities/Veterans/Disability

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