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Reference Number:
10-07622
Job Description:
This position is responsible for the executive management of 3rd Party Device- and Pharmacovigilance (D&Pv) Partnerships/Alliances relevant to the Pharmaceutical Consumer companies; collaborates with the Senior Leadership of Pharmaceutical Consumer Companies and BRM to ensure end-to-end partnering with the 3rd Party on Product D&Pv; takes appropriate action in case of D&Pv Alliance issues and, in collaboration with the Head PAM, decides the escalation path.
This position leads the complete process around 3rd Party ? Pharmaceutical Consumer relevant D&Pv Agreements (initial and renewals) and conducts negotiations with the 3rd Party. Ensures Pv Agreements are executable and compliant with all applicable Law and Regulations. Collaborates in this effort with BRM Legal Counsel, appropriate Pharmaceutical Consumer and BRM Functions.
Upon request from Pharmaceutical Consumer Business Development, this position will participate on D&Pv in Due Diligence efforts. Where appropriate, he/she liaises with Chief Safety Officer Consumer, the EEA QPPV Consumer and other relevant stakeholders in Pharmaceutical Operating Companies.
Principal Responsibilities:
Executive management of the Pharmaceutical Consumer-related D&Pv Partnerships/ Alliances. In collaboration with Pharmaceutical Consumer and BRM Senior Leadership:
? Where applicable, based on the D&Pv Agreements, provide directions and advice to BRM functional representatives who handle the operational and technical issues on a daily basis
? work with all stakeholders, including but not limited to Consumer Center for Product Quality, Consumer Office Safety and Technology to ensure end-to-end management and safety oversight of mixed product quality and adverse event or device safety reports
? determine the Product Integration path; prepare a draft Transfer Plan
? determine need for a product Safety Oversight Working Group; prepare set-up with Partner and Company representation, if applicable
? monitor the Alliance; in case of issues take appropriate action and, in collaboration with Head PAM, determine escalation path
? monitor resolution of mutually agreed corrective actions
Further:
? develop controlled process documents (SOP) for Pharmaceutical Consumer Operating Companies to manage contractual aspects of D&Pv for all relevant agreements between Operating Companies and 3rd Parties
? develop and maintain appropriate D&Pv Agreement template text
Team leader for Pv Agreements; partnering with Legal Counsel, global/regional Business Development and Marketing Partners of the Pharmaceutical Consumer business:
? ensure BRM functional buy in to the terms of a prospective D&Pv Agreement; determine the appropriate, named functional contacts
? ensure the final D&Pv Agreement is both executable and compliant with applicable Law and regulations
? implement the timely revision of existing D&Pv Agreements of Pharmaceutical Consumer Operating Companies with 3rd parties
Upon request from Pharmaceutical Consumer Business Development, participate in Due Diligence (L&A, M&A) efforts; evaluate the D&Pv process and Product Safety components of global /regional product and/or company licensing and/or acquisition opportunities:
? Contribute to the relevant sections of Due Diligence Report; i.e. the PV organization; documentation of procedures; information management; case processing; signaling; single case and aggregate reporting; labeling; audits/inspections; and, any program specific issues
? Where appropriate, ensure that known/suspect Safety Issues emerging from the Due Diligence are communicated appropriately to the initiating Pharmaceutical Consumer Companies, the Consumer Chief Safety Officer and, where applicable, to the EEA QPPV - Consumer
? Where appropriate, conduct research to deliver Product Adverse Event Volume/Workload Estimates as input to the draft Transfer Plan for BRM
Decision Making Responsibilities
? Works within matrix BRM, Pharmaceutical Consumer Office of Safety and Technology and 3rd Party teams to ensure that the Product Safety and D&Pv-relevant exchanges in the Alliance are consistent with the terms of the Pv Agreement. Where necessary, initiates unscheduled review of the Pv Agreement.
? Applies the appropriate tools to monitor D&Pv Alliances/Partnerships and takes action where (potential) issues might arise. Escalates, applying judgment; goal is to optimize and sustain Alliances with the minimal necessary resources.
? Recommends to the BRM Senior Leadership decisions regarding BRM commitments in contractual agreements supporting Products marketed by Pharmaceutical Consumer Companies. To be taken into account are applicable Law and Regulations, BRM resources, policies and internal company standards
Experience Level:
Unspecified
Requirements:
? A minimum of a Bachelor?s degree is required (graduate level highly preferred) in a relevant discipline; Medical, or additional Business or Legal qualification is of interest
? Applied knowledge of applicable Law and Regulations governing Pharmacovigilance and Device Safety Reporting on global level
? Working experience in a drug safety organization at a significant level of operational responsibilities
? Ability to communicate clearly and concisely in verbal and written form
? Excellent negotiation and networking skills
? Demonstrated problem solving ability
? Demonstrated ability to lead, and generally to excel working in matrix teams
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