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Medical Director, Worldwide Drug Safety

Company: Pfizer
Location: Trenton
Posted on: September 14, 2020

Job Description:

Medical Director, Worldwide Drug Safety

Pfizer's Worldwide Drug Safety organization is excited to present a Medical Director position.

Role Summary

The Medical Director, Worldwide Drug Safety assures that individual case assessments for all report types are completed in a timely manner to allow appropriate submissions to Health Authorities worldwide. In addition, the Medical Director recognizes safety signals during daily activities which are shared with Safety Surveillance and Risk Management and other Worldwide Safety and Regulatory functional groups to monitor the safety profile of assigned products. Finally, continuous interaction with the Therapeutic Area Head allows proactive, prompt and effective communication of any product safety issues that arise.

Role Responsibilities

* Perform single case medical assessment in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Working instructions, Argus User Reference Guide and case processing/coding conventions

* Maintain timely submission of expedited reports

* Identify cases that meet SUSAR reporting criteria, request the SCA/AOSE, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process, if needed, and complete the report so that it is available for appropriate distribution

* Recognize and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems. Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders

* Partner with Safety Surveillance and Risk Management and with other Worldwide Safety and Regulatory functional groups to monitor the safety profile of assigned products

* Work with the Therapeutic Area Head to proactively and effectively communicate product safety issues

* Provide medical advice and insights to Therapeutic Area colleagues to improve the quality, consistency, accuracy, and clinical relevance of safety reports

Basic Qualifications

* Doctor of Medicine or Doctor of Osteopathic Medicine

* Ability to make independent clinical assessments, based on professional and scientific responsibilities to patients, prescribers, regulators, and providers

Preferred Qualifications

* Previous experience in Pharmaceutical company(s) in Safety/Pharmacovigilance

* Specialization in Oncology/Onco-hematology

* Comprehensive knowledge of current regulations governing the processing and reporting of safety data

* Ability to interact with Regulators during inspections

* Hands-on understanding of the use of safety databases for adverse event evaluation and reporting

Other Job Details:

* Last Date to Apply for Job: September 21, 2020

* Additional Location Information: Preference for Peapack, NJ but also open to US remote based

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.

Medical

United States - New Jersey - Peapack * Doctor of Medicine or Doctor of Osteopathic Medicine * Ability to make independent clinical assessments, based on professional and scientific responsibilities to patients, prescribers, regulators, and providers, * Previous experience in Pharmaceutical company(s) in Safety/Pharmacovigilance * Specialization in Oncology/Onco-hematology * Comprehensive knowledge of current regulations governing the processing and reporting of safety data * Ability to interact with Regulators during inspections * Hands-on understanding of the use of safety databases for adverse event evaluation and reporting

Keywords: Pfizer, Trenton , Medical Director, Worldwide Drug Safety, Other , Trenton, New Jersey

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