6 days old

Pharmacovigilance (PV) Licensing Lead Manager

Collegeville, PA 19426
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We have an exciting opening for a Pharmacovigilance (PV) Licensing Lead Manager.

The PV Licensing Team partners globally with Pfizer Business, Legal, Safety and Regulatory colleagues in delivering strategic input to Pfizer Commercial Partnerships to ensure compliance with Global Health Authority requirements. In this role you will have the opportunity to interface with partner biopharmaceutical companies for the preparation and maintenance of Pfizer's Pharmacovigilance Agreements (PVAs). As a subject matter expert for PVAs, you will also liaise the communication with the safety organizations of the respective partners, and maintain the PVA obligations for reference in a dedicated database - Pharmacovigilance eXchange (PvX).

**Role Summary**

+ Develop Pharmacovigilance Agreements (PVA) and support processes. Provides guidance to and/or may lead/co-lead projects for PV Licensing colleagues supporting WWS

+ In collaboration with leadership of WWS 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

**Role 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

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

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

+ Sets 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.).

+ Applies 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. Receives instruction primarily on unusual problems; solicits directional review from others; may review work completed by other colleagues when acting in mentor role

+ Uses a variety of communication tools and techniques to inform difficult concepts with relevant functional lines to support Contractual Partner relationships; regularly takes informal leadership role during team meetings to facilitate agreements and move toward goals; takes 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 participates in periodic operational staff meetings to share best practice, continuous improvement, to pro-actively address issues; frequently initiates topics and solutions

**Basic Qualifications**

+ Bachelor's degree required

+ 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

+ 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

**Preferred Qualifications**

+ Advanced degree in scientific or technical area preferred

+ Experience in process review, management and change management preferred

**Other Job Details:**

+ **Last Date to Apply for Job: April 2, 2020**

+ Additional Location Information: Preference for position to be based out of Collegeville, PA but also open to any US or global Pfizer Site

+ Eligible for Employee Referral Bonus


**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Posted: 2020-03-23 Expires: 2020-04-23

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Pharmacovigilance (PV) Licensing Lead Manager

Collegeville, PA 19426

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