Clinical Research Physician

Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Our Pfizer Clinical Research Unit (PCRU) in Brussels is a state-of-the-art research facility with sixty inpatient beds dedicated to early clinical trials (Phase 1 & 2a studies).

Location: Anderlecht, Brussels.

For this position you have aMedical Degree with a valid license to practice medicine and you are registered with the order of doctors in Belgium.

You have at least a first experience as a doctor in a hospital environment.

JOBRESPONSIBILITIES

As an Investigator

• Assumes accountability for all medico-legal, scientific integrity, human safety and medical governance aspects of PCRU studies.
• Liaises with other Pfizer sites regarding the design, conduct and progression of studies in the PCRU.
• Assists with the medical and clinical oversight of all aspects of function and work performed within the PCRU.
• Participates in the planning, execution and data review for allocated studies.
• Works directly with clinical research personnel in reviewing data, performing physical assessments, medical histories, and evaluation of inclusion/exclusion criteria for study participants.
• Participates actively in the review/correction/update and approval of study data, especially the review and coding of adverse events and concomitant medications.
• Supports the implementation and application of electronic health record system (PIMS) in the PCRU.
• Supports the development of Informed Consent Documents for allocated studies and assists in obtaining the consent from study participants

As a Principal Investigator

• Assumes accountability and responsibility for the execution of the allocated clinical trials.
• Facilitates and coordinates the conduct of Phase I-IIa-IV studies, including Early Development and Full Development Clinical Pharmacology studies (protocol development, review, Regulatory and IEC submissions).
• Provides support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents as requested.
• Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data, to establish the presence or absence of abnormal trends, and if noted, follow-up as appropriate with the PCRU clinical team, the PCRU project team, the sponsoring Pfizer site, and regulatory agencies.
• Participates in the review of individual adverse event reports for accuracy and clinical importance, and characterizes their relationship to the study drug, severity and seriousness.
• Ensures that all established timelines relating to areas of responsibility and assigned projects are met.
• Ensures that the quality standard of clinical work product is met.

Other

• Develops a good working knowledge of study management and a full understanding of ICH-Good Clinical Practice and Pfizer SOPs, Work instructions and Guidances.
• Develops a good working knowledge of clinical trial activities within the industry and pass this on to less experienced staff.
• Liaises with University Hospitals as necessary in their areas of expertise and joint projects.
• Develops productive working relationships with hospital colleagues and with colleagues at the PCRU and at other Pfizer sites to facilitate the performance of the duties and continued development as a Clinical Research Physician.
• Familiarizes with the practice of pharmaceutical medicine through the literature and by attending appropriate training, meetings and conferences.
• Liaises effectively with all members of the PCRU and make a positive contribution towards team spirit in the PCRU.
• Performs regular On-Call duty to ensure the continuous conduct of clinical trials.
• Takes part to On-Site Recall duty 24/7 in case of need or urgency.

Additional responsibilities after acquisition of relevant experience in Phase 1 clinical research activities

• Represents the PCRU on company-wide initiatives in their area(s) of expertise.
• Represents Pfizer in external environments (e.g., scientific meetings, advisory meetings, etc.) in their area(s) of expertise.
• Develops, maintains and shares subject matter expertise on Clinical Pharmacology and/or Biomarker Methodology topics and studies.
• Act as the expert Physician in Phase 1 clinical research for Worldwide Research and Development, Global Product Development, Clinical Development and Operations, and participate to global clinical research committee such as CPSDC.

Training

• Participates in training courses related to clinical research, pharmaceutical medicine, pharmacology as appropriate.
• Assists in the training of PCRU staff and contractors with less experience and expertise.
• Develops knowledge to be responsible for compliance with Pfizer Standards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation.

QUALIFICATIONS / SKILLS

• Medical Degree with a valid license to practice medicine and you are registered with the order of doctors in Belgium.
• A post-graduate qualification in a general medical specialty, or an equivalent experience is an asset.
• Evidence of continuing education/training relative to drug development/study conduct/pharmaceutical medicine is a plus.
• 2 to 3 years of clinical experience, with preferably part of it in clinical trials.
• Knowledge of the EU regulations for drug development process is helpful.
• Your are fluent in English and Frenchand have some understanding of Dutch.

ORGANIZATIONAL RELATIONSHIPS

• Reports to Clinical Operations Director.
• Networks and collaborates with other Pfizer CRUs to ensure organizational consistency of standard operating procedures.
• Functional relationship to the Clinical Services Director, Business Operations Director, Pharmacy and Regulatory Director, Medical and Scientific Advisor, and Safety Laboratory Head in areas of safety, ethical and regulatory oversight for study participants.
• Matrixed relationship to study team and other peers in the PCRU (provides guidance for group study management activities), varied scientists and clinicians in Clinical Sciences to design protocol, and multiple Worldwide Research and Development departments (Dev. Ops., Assay Laboratory, Pharm. Sciences) to implement and report outcome.
• Operations point of contact for internal departments, external consultants, technical equipment and supply vendors.
• Act as Unit Representative towards other Pfizer and non-Pfizer departments and customers.
• Collaborates across Development and Discovery departments.

What we can offer you

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. Pfizer’s open-door policy is an integrated part of our culture across all levels of seniority.

We offer competitive salaries and benefit packages and unparalleled opportunities for career growth.

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. Should you have any question or specific needs regarding this hiring process, please contact : Albena.Zabtcheva@Pfizer.com .

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