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Pharmacovigilance Agreements (PVA) Licensing Lead Manager


Collegeville, PA 19426
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Job Details

Pfizer has an exciting opportunity for a Pharmacovigilance Agreements (PVA) Licensing Manager to join our global Safety and Regulatory Organization. Reporting to the PV Licensing Team Lead, Pharmacovigilance Strategy Policy and Standards (PSPS), the incumbent will:

+ Develop Pharmacovigilance Agreements (PVA) and support processes. Provide guidance to and/or may lead/co-lead projects for PV Licensing colleagues supporting our Worldwide Safety & Regulatory (WSR) organization.

+ In collaboration with leadership of WSR functional lines, drive and implement relevant planning, execution, and governance strategies associated with PV Licensing arrangements.

+ Responsible for alignment with Business Development and BU/RU goals as it relates to the overall delivery of quality PV Licensing agreement deliverables.

+ Participate in and be a key contributing member of strategic PV Licensing improvement activities for continuous system development and improvement.

**Primary Responsibilities**

+ PVA development- own end-to-end process of development, execution, maintenance, and termination (when applicable) of PVAs and associated deliverables. May include strategy setting, with input as necessary from line management.

+ Responsible for quality of PV Licensing work product.

+ Provide guidance to and/or may lead/co-lead projects; develops and manages plans to achieve objectives

+ Manage own time to meet objectives; applies skills and discipline knowledge to contribute to the achievement of work.

+ Set tactical approaches and drive more effective, operational plans for delivery of PVAs. Has comprehensive knowledge of the principles, concepts and theories of the discipline, and good understanding/knowledge of principles and concepts of other disciplines.

+ Consolidate partnerships to promote awareness and understanding of PV Licensing processes and deliverables to ensure effective collaboration and critical inputs with key internal/external interfaces (Regulatory, Business Development, Legal, BU/RU, Contractual Partner, etc).

+ Apply technical and line knowledge of key concepts in own discipline

+ Face decisions that may require developing innovative options to resolve problems. Able to operate independently in ambiguous situations within Sub Business Unit/Sub Operating Unit; decisions impact work of multiple functional lines and stakeholders; may become a resource for others. Receive instruction primarily on unusual problems; solicit directional review from others; may review work completed by other colleagues when acting in mentor role.

+ Use a variety of communication tools and techniques to inform difficult concepts with relevant functional lines to support Contractual Partner relationships; regularly take informal leadership role during team meetings to facilitate agreements and move toward goals; take responsibility for a portion of the team's deliverables; may lead operational team(s); can initiate, conduct or lead PV Licensing strategy meetings with minimal guidance.

+ Build strong relationships with relevant customers and stakeholders across PFE to drive collaborative partnership with PV Licensing team.

+ Actively participate in periodic operational staff meetings to share best practice, continuous improvement, to pro-actively address issues; frequently initiates topics and solutions.

**Technical Skill Requirements**

+ Project and process management, including project prioritisation.

+ Working individually, within a dedicated technical team and within a matrix organisation.

+ Good understanding of key global pharmacovigilance regulations.

+ Communication, negotiating and decision making.


+ Bachelor's degree required, advanced degree in scientific or technical area preferred.

+ 5+ years pharmaceutical industry experience required

+ Safety/Pharmacovigilance, Regulatory or Clinical development and business experience required in order to have a thorough understanding of the processes associated with operational aspects.

+ Experience in contract management

+ Experience in process review, management and change management preferred.

+ Knowledge and understanding of project resource needs, ability to translate project requirements into effective contracts.

+ Analytical and strategic thinking skills.

+ Effective influencing and negotiating, interpersonal, leadership, and team player skills.

+ Presentation and communication skills

**Other Job Details:**

+ **Last Date to Apply for Job: February 9, 2018**

+ Additional Location Information: Collegeville, PA and any Global Pfizer Site

+ Eligible for Employee Referral Bonus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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