Pharmacovigilance (PV) Licensing Lead Manager

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

• Develop Safety Data Exchange Agreements (SDEA) 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 SDEA deliverables.
• Participate in and be a key contributing member of strategic PV Licensing improvement activities for continuous system development and improvement.

How You Will Achieve It

• SDEA development- own end-to-end process of development, execution, maintenance, and termination (when applicable) of SDEAs 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 SDEAs. 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.

Qualifications

Must-Have

A scientific or technical degree is preferred.  In general, candidates for this job would have the following levels of education/experience:

• Bachelor’s degree and extended industry experience.
• Safety, Regulatory or Clinical development and business experience 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.

Nice-to-Have

Experience in process review, management and change management preferred.

  

Other Job Details:

• Last Date to Apply for Job: 17 OCTOBER 2024.
• Eligible for referral bonus.
• NOT eligible for relocation

Work Location Assignment: Flexible

Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.

The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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