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Director, PV Contracts and Agreements

Company: BeiGene, Ltd.
Location: Ridgefield Park
Posted on: February 16, 2021

Job Description:

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description:
The Director, PV Contracts & Agreements leads the global team of PV contract managers and is responsible for ensuring that the global strategic approach as well as the day-to-day operating requirements for pharmacovigilance contracts and agreements is effectively managed and objectives achieved in order to maximize the strategic value of BeiGene's alliance partnerships. This position contributes to the establishment of tools, processes, and strategies employed by Global Safety Operations and Innovation to ensure effective coordination between Business partners as well as to proactively manage compliance risks. Essential Functions of the job:
Contracts & Agreements Strategy & Planning

  • Leads PV contracts and agreements strategy, staying abreast of BeiGene business development, and commercial activities to ensure contractual obligations are met.
  • Provides oversight on matters related to PV contracts and agreements on behalf of the EU QPPV
  • Represents GPS as a key advisor to the business on matters related to PV contracts and agreements requirements and participates in planning activities to support and facilitate business development
  • Leads the development and implementation of a scalable process for managing and tracking PV contracts and agreements including Safety Data Exchange Agreements (SDEA) and associated templates
  • Partner with key stakeholders to contribute to the development and maintenance of a global PVA template
  • Act as a key contact point on all matters relating to SDEAs/ PVAs with internal stakeholders (e.g. Safety, Quality, Regulatory, Business Development, Alliance Managers, Supply, Commercial, Legal, Affiliates) as well as external business partners.
  • Builds enterprise knowledge around GPS PV contracts and agreements processes and systems utilized to create and execute agreements.
  • Ensure oversight on all SDEA contractual obligations and associated deliverables throughout the lifecycle of business partnership.
  • Oversees the organization and conduct of periodic reviews of the adequacy of existing PV contracts and agreements and initiates revisions, where appropriate
  • Proactively identifies risks or points of disagreement with business partners and addresses issues in a time-sensitive manner, engaging senior leadership as required
  • Leads contributions to the maintenance of legal procedures used in the execution of pharmacovigilance contracts
  • Ensures ongoing alignment of PV contract and agreements processes with global PV legislation
  • Supports Business Partner due diligence activities on behalf of GPS, as required
  • Plans and conducts best practice and knowledge sharing forums with internal stakeholders and external advisory groups. Contracts & Agreements Execution
    • Lead the preparation, negotiation and conclusion of SDEAs/PVAs relating to Development and Commercial partnerships.
    • Works with potential partners and internal legal team on agreements and contracts.
    • Ensures compliance with contractual obligations, by effectively understanding and communicating such obligations both internally and externally.
    • Collaborate with the PV Compliance group to address and resolve compliance issues associated with PVAs
    • Provides leadership and guidance in the identification and resolution of issues with PV alliances/partnerships.
    • Provides support to local and regional affiliates and business partners in the review and execution of pharmacovigilance contracts
    • Accountable for integrity of all PV agreement content incorporated into Pharmacovigilance System Master File (PSMF) Other
      • Ensure compliance with company guidelines, legal and regulatory requirements and industry practice.
      • Contributes to the preparation and execution of internal audits of pharmacovigilance contractual partners and supports the management of outcomes
      • Serves as subject matter expert for audits and inspections of the GPS pharmacovigilance system Supervisory Responsibilities:
        • Accountable for 3+ resources involved in the negotiation and execution of PV contracts and agreements Education Required:
          • Bachelor's degree in life sciences, pharmacy, nursing or equivalent Experience
            • Minimum of 8-10 years of experience working with pharmacovigilance contracts and agreements
            • Expert negotiation skills and demonstrated ability to identify areas of mutual interest required to achieve agreement
            • Demonstrated experience of managing resources responsible for PV contracts and agreements
            • Expert command of global pharmacovigilance agreement regulations and guidelines including but not limited to EU Good Pharmacovigilance Practices (GVP)
            • Proven track record of supporting compliance within the PV space Other Qualifications:
              • Experience of the management of Individual Case Safety Reports (ICSRs) and Aggregate Reports
              • Strong interpersonal and presentation skills, including the ability to liaise with senior leaders
              • Excellent oral and written communications
              • Ability to deal with ambiguity and make decisions within a high-growth, rapidly evolving environment
              • Strong analytic and strategic thinking skills with attention to detail Travel: International and domestic, 20% Competencies:
                Negotiation - Applies principles of collaborative negotiation (i.e. constructive, principled or interest-based negotiation). Treats relationships as an important and valuable element during negotiations and seeks equitable and fair agreements.
                Quality & Compliance - Good understanding of the need for data accuracy, completeness consistency and integrity. Understanding of the application of six-sigma and other techniques and tools for process improvement
                -- Data Analysis - Ability to draw out main messages from data analysis and research, and identify essential supporting information
                -- Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
                -- Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
                -- Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
                -- Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
                -- Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
                -- Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
                -- Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
                -- Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
                -- Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
                -- Problem Solving - Ability to anticipate and contribute to the effective resolution of compliance issues. Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
                -- Critical Thinking - Identifies how different possible approaches are strong or weak and analyzes these judgments. We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Posted 30+ Days Ago Full time R5216 About Us BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Currently employees are located in APAC, United States and Europe. BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, see

Keywords: BeiGene, Ltd., Clifton , Director, PV Contracts and Agreements, Executive , Ridgefield Park, New Jersey

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