Director, Pharmacovigilance (PV) Vendor Relationship Management (VRM)
- Jersey City, NJ
Entrepreneurial Verve, Rooted in Tradition. At MT Pharma America, we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma, is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new Commercial organization and expanding our other functions to support this strategy.
The Director, PV VRM will provide pharmacovigilance-specific relationship activity management between MT Pharma America, its’ affiliates and external business partners involved in the delivery of contracted services such as the MCI-186 product Information HUB, medical information Call Center and Specialty Pharmacy partners. This individual will work with internal and external partners to ensure that all MT Pharma America and affiliates’ safety policies are followed to ensure compliance with all safety reporting requirements. The Director will interact with designated vendors for proactive identification and resolution of PV-related questions and issues, monitor vendor operational delivery (e.g., compliance with SOPs, quality standards, etc.), identify opportunities for improvement (resource, process, performance) and lead change implementation in partnership with the vendors and internal stakeholder departments (i.e., Regulatory Affairs, Commercial, QA, Legal, and Finance).
Establish policies for VRM related to PV/Drug Safety that fosters internal and external commitment to shared goals for optimal vendor performance for contracted services supporting the PV system.
Partner with vendors for resolution of safety operational issues and questions, identify vendor training needs and opportunities for improvement, and ensure implementation in collaboration with internal stakeholders.
Partner with safety leadership to provide effective oversight, coordination and communication between the company and its’ vendors/contracted partners in support of compliant and high-quality delivery of pharmacovigilance-related services.
Oversee outsourced operational activities and measure vendor performance through Key Performance Indicators/Metrics according to contracted Service Level Agreements.
Direct stakeholder management & communication, including escalation of performance and delivery issues at vendor to functional management and/or governance committees.
Collaborate with cross-functional departments (QA, Medical Affairs, Health Systems, Regulatory Affairs) on audit activities relating to the vendor, initiatives to streamline operational issues between the vendor and Safety Team and other vendor related programs, for example, REMS programs if required or product registry if conducted.
Participate with safety team in vendor training activities around Adverse Event (AE) reporting.
Prepare and/or review relevant company and vendor controlled documents to ensure cross-functional/cross-company alignment and to ensure global PV requirements are met.
Coordinate integration to company network and the global safety database as appropriate.
Undertake additional projects, as assigned, in support of Safety and or other business goals. Proactively identify opportunities to continuously improve process and operations between the company and vendors.
Assess program issues and areas of risk and notifies company leadership to find solutions.
Health Care Professional Degree (e.g. RN, BSN, PA, NP, BPharm) or Life Science Degree (e.g. BSc Pharmacology, BSc Biology, BSc Neuroscience, etc.), or equivalent experience is required.
Postgraduate Degree (MSc, PhD, PharmD) is strongly preferred.
Extensive experience in pharmaceutical safety, with 3+ years in a management role - or - 5+ years in a role focused on vendor partnership/relationship management
Demonstrated experience in managing business relationships with third party vendors in the pharmaceutical industry such as product HUBS.
Experience with specialty (infusion) products and Specialty Pharmacies is preferred.
Knowledge and Skills:
Knowledge of global Pharmacovigilance regulatory obligations.
Proven abilities in managing multiple, often complex, and sometimes competing, projects, objectives, goals and other priorities to effective and efficient conclusion.
Excellent leadership, management and communication skills, demonstrating vision, commitment and credibility.
Ability to work effectively within a matrix organization to achieve desired outcomes.
Ability to interact successfully with senior leaders on strategic/global projects and issues.
Proven track record of effective decision-making; exercises sound judgment to analyze problems from multiple perspectives.
Outstanding interpersonal and cross-cultural skills; builds strong sustainable relationships with internal and external stakeholders.
Strong communication skills, demonstrating professional maturity, confidence and competence.
Excellent leadership competencies including negotiating, conflict management/resolution, influencing, and leading without authority.
Willingness to travel up to 25% percent.
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, MT Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
Medical/Dental | Life Insurance | Supplemental Life Insurance/Dependent Life Insurance | Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee’s Savings Plan (401K Plan) | Competitive Paid Time Off