Outsourcing PV Scientist


    Randstad Construction & Property

    Outsourcing Oversight Manager, PV Scientist

    Job Description:

    The Outsourcing Oversight Manager, PV Scientist is a pivotal member of the vendor management team, overseeing outsourced activities within the Safety Surveillance and Aggregate Report (SSA) group. These activities encompass the planning and production of aggregate reports, risk management plans, and signal detection services. The role involves managing multiple vendors, improving SSA processes, and ensuring high standards of quality, accuracy, and efficiency.

    Key Responsibilities:

    • Vendor Engagement:
      Collaborate with multiple vendors across various functions, including literature review, external database mining, signal detection, and aggregate report generation.
    • Sourcing Strategies:
      Assist in developing sourcing strategies for RFPs, aligning business requirements for new vendors.
    • Scope of Work:
      Support the review and development of Scopes of Work on behalf of the business, facilitating contract execution in collaboration with stakeholders.
    • Relationship Manuals:
      Facilitate regular updates and reviews of the vendor Relationship Manuals.
    • Vendor Activities Oversight:
      Oversee vendor activities, including onboarding processes such as IT setup, training, communication, and SharePoint management.
    • Process Improvement:
      Develop new procedures and tools to enhance vendor oversight and streamline SSA processes.
    • Training and Communication:
      Create and deliver training to ensure effective communication between vendors and Biogen stakeholders.
    • Performance Monitoring:
      Monitor Key Performance Indicators and vendor performance metrics.
    • Forecasting and Budgeting:
      Involved in vendor workload forecasting and budget management.
    • Administrative Tasks:
      Perform general administrative duties, such as maintaining spreadsheets, monitoring shared email distribution lists, and managing SharePoint.
    • Inspection and Audit Support:
      Provide support during inspections and vendor audits.
    • Relationship Building:
      Build and maintain strong relationships with vendors and multi-functional teams globally.
    • SSA Support:
      Address SSA-related queries concerning safety database outputs, vendor management, and SharePoint.
    • Tracking and Monitoring:
      Assist in tracking and monitoring activities for the SSA team.
    • CAPA Support:
      Support Corrective Action and Preventative Action (CAPA) plans and their effectiveness checks.

    Skills and Qualifications:

    • Pharmacovigilance Knowledge:
      Pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations.
    • Knowledge of case processing, expedited reporting rules, and safety database concepts.
    • Aggregate Reports and Risk Management:
      Ideally knowledgeable about aggregate reports, signal detection processes, and risk management plans.
    • Vendor Oversight:
      Basic experience with outsourcing and vendor management.
    • Scientific Communication:
      Ability to interpret, analyze, and present scientific and medical data clearly in both verbal and written formats, with an understanding of medical concepts and terminology.
    • Editorial Skills:
      Strong editorial, technical, and scientific writing skills.
    • Team Collaboration:
      Effective in a team environment with strong interpersonal skills.
    • Organizational Skills:
      Excellent communication and organizational abilities, with independent prioritization skills.
    • Software Proficiency:
      Knowledge of common data processing software (SharePoint, EXCEL, PowerPoint, Microsoft Word, Business Objects) and safety database systems.
    • Scientific Judgment:
      Ability to apply scientific judgment in interpreting case information.

    Education and Experience:

    • Bachelor’s Degree in biologic or natural science, or healthcare discipline. An advanced degree (PhD, MPH, NP, PharmD, etc.) is preferred.
    • 5 years of experience in the pharmaceutical or biotech industry.

    Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

    Candidates must be eligible to live and work in the UK.

    For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.