Associate Director, Pharmacovigilance

  • Location:Cambridge, MA
  • Department:Pharmacovigilance
  • Type:Full Time
  • Min. Experience:Senior Manager/Supervisor

       

      Covid- 19 Mandatory Vaccination Requirement

      Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe.  Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.

       

      SUMMARY

      The Associate Director, Pharmacovigilance (PV) will lead PV activities across Surface products in clinical development.  The PV, AD role will oversee the operational aspects of the PV systems, manage PV vendors, and coordinate the execution of safety deliverables including aggregate reports and signal detection activities.

       

      RESPONSIBILITIES

      • Provide strategic planning, implementation, and management of PV day to day operations activities
      • Provide vendor oversight and management for all outsourced or insourced PV activities and from set up of the vendor relationships vendor relationships (e.g., business requirements, vendor selection, contract details, vendor oversight / safety management plans) to ensuring inspection-ready documentation of oversight
      • Partner with cross-functional colleagues including but not limited to Clinical Operations, Medical, Quality and clinical collaboration partners in the generation, review and approval of governing documents, such as SOPs, Operating Guidelines and Safety Management Plans and ensure operational implementation
      • Ensure the Global Safety Database supports the department needs, including specific workflows and reporting/querying functionalities. Provides oversight of systems and MedDRA updates in collaboration with the relevant vendors
      • Ensure timely submission of expedited safety reports and other external submissions through effective vendor management and performance metrics review
      • Provide PV operational support to clinical trial study teams
      • Collaborates with other key stakeholders to provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards and metrics
      • Serve as PV Subject Matter expert (SME) during audits and inspections in the areas of case processing/case management activities, literature monitoring, metrics, vendor oversight, etc.
      • Act as the primary PV contact within the company and across clinical collaborations
      • Guide and author PV sections of protocols, IBs, CSRs and other documents including aggregate safety reports [e.g., DSURs, PSURs, etc.]
      • Facilitate Safety Review Committee meetings, ensuring Signal Detection oversight to identify risks and drive resolution to identified issues
      • Provide vendors with resources and training to perform their role

       

      QUALIFICATIONS

      • PharmD or RN preferred.  Master’s or bachelor’s degree in the life sciences or related will be considered with applicable job experience.   Oncology experience required, immuno-oncology preferred.
      • Minimum 8 years of industry experience with a demonstrated focus in PV operations and compliance (e.g., including case processing, SAE reconciliation, compliance metrics, ICSR quality metrics, CRF design review, and protocol review
      • Proven ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources
      • Strong knowledge and experience with currently available drug safety data base systems (preferably ARGUS), document management systems and QC tools including MedDRA
      • Experience in managing business partner / vendor relationships
      • Expert knowledge of FDA and EU legislation and International Conference on Harmonisation (ICH) PV guidelines and Good Clinical Practices (GCP) guidelines
      • Experience in the preparation and authoring of aggregate safety reports including reviewing cumulative safety data with ability to interpret, synthesize, communicate, and present complex clinical /pharmaceutical information
      • Thorough understanding of drug development and safety surveillance activities
      • Demonstrated technical, administrative, and project management capabilities
      • Independently motivated, detail oriented with strong problem-solving ability
      • Excellent organizational skills and demonstrated ability to effectively balance competing priorities
      • Strong written and verbal communication skills with the ability to collaborate cross-functionally
      • Experience developing of SOPs, Templates, and Working Practices
      • Proficiency with standard office software (Microsoft Office Suite)