European Safety Office (ESO) Medical Senior Manager

Pfizer is hiring a European Safety Office Medical Senior Manager to support the Pfizer pharmacovigilance system and the adequate surveillance of the safety profiles of Pfizer products of European (all European Union Member States and the three EFTA countries Iceland, Liechtenstein and Norway) interest, both marketed and under development with intent to register (registration-targeted clinical activities started), for one or more therapeutic areas; to report and interact on these safety profiles with the European Drug Agencies; and to provide advice for Europe-related purposes, such as regulatory actions and documents, product labeling, risk management, safety data exchange agreements, and clinical trial programs.
Primary Responsibilities

• Keep permanently updated on EU Pharmacovigilance regulations and policies.
• Ensure support the EUQPPV and Deputy in fulfilling safety qualified person obligations in Europe.
• Support the activities of WMS, as appropriate, including development of relevant processes and practices, with particular reference to European Directives, Guidance and Points to Consider.
• Ensure support to the EUQPPV in the monitoring of compliance (time and quality) for expedited individual and aggregated data reporting, of product issues (including recalls), and of overall performance as regards safety in Europe.
• Partner with relevant functions to ensure the monitoring of cumulative safety data for products approved in Europe as well as products in development with intent to register, and to support safety signal generation and evaluation activities, in one or more specific therapeutic area(s) of responsibility.
• Participate directly or via a designee to Risk Management Committees and benefit/risk governance bodies as required.
• Partner with relevant functions to support and ensure the appropriate and timely delivery of high quality aggregated data reports and other regulatory documents for European Health Authorities, in compliance with European requirements, for all products within the therapeutic area(s) of responsibility.
• Ensure the timely and quality review of aggregate data reports, safety data exchange agreements, labelling (Core Data Sheet and, for CAP and MRP products, SmPC), pharmacovigilance and risk management plans, and other documents (e.g. protocols for post-authorisation safety studies, study reports).
• Partner with relevant functions to support the definition and update of product safety profiles and labelling in Europe.
• Support the functions responsible for submission of individual reports to the EudraVigilance database.
• Globally monitor all safety related matters potentially impacting on Europe.
• Collaborate with the safety functions within WMS, as well as other departments, as appropriate, to ensure effective collaboration on all European issues.
• Represent PFE at drug agencies in Europe where required.
• Support the PFE country-based safety units as regards pharmacovigilance aspects of European relevance.
• Support the monitoring of the status of PFE products in Europe, including commitments, and the monitoring of the evolution of the European regulatory/methodological/ philosophical approaches to drug safety.
• Maintain the documentation systems pertaining to the EUQPPV activities.
• Selection of adequate personnel, and their training in pharmacovigilance and relevant processes and procedures.
• Ensure that each role in the function has an adequate job description.
• Ensure that policies and procedures are in place and maintained to guarantee quality and timeliness of deliverables.

Qualifications

• Medically qualified (MD certification or equivalent). Higher medical degree or specialization, experience in clinical research preferred, experience in epidemiology preferred.
• Sound medical knowledge.
• Previous experience in the pharmaceutical industry in pharmacovigilance or clinical research departments on an international level.
• Good understanding of computer technology, and management of relational database systems.
• Fluency in written and verbal English. Working knowledge of at least one other European language preferred.

Technical Skill Requirements

• Expertise in medical aspects of pharmacovigilance, scientific basis for therapies and drug-induced diseases.
• Understanding of pharmacovigilance internal and external environment, including scientific, methodological and regulatory aspects with a special focus on European requirements.
• Understanding of product development and clinical research.
• Demonstrated ability to analyze, frame, and communicate complex issues and their strategic implications for patient safety, including scientific writing and presentation proficiency.
• Ability at operating in a matrix environment.
• Good oral and written communication and presentation skills.
• Good communication and negotiation skills with internal and external parties.
• High skills in time management and organization.

Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Pursuant to Article 24(6) of the Act of June 24, 2024 on the protection of whistleblowers, Pfizer Polska Sp. z o.o. and Pfizer Trading Polska Sp. z o.o. declare that they have adopted a joint internal reporting procedure, which, in accordance with the provisions of the aforementioned Act, is also available to persons applying for employment on the basis of an employment relationship or other legal relationship constituting the basis for providing work or services or performing functions. The content of the procedure is made available upon request sent to the contact person or to the email address [email protected].
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