Pfizer Associate Medical Director in Peapack, New Jersey
The Associate Medical Director (Product Safety Surveillance Reporting MD) perform the medical assessment activities related to drug safety pharmacovigilance for the assigned therapeutic area(s). The PSSR MD proactively evaluates safety information from individual cases and cumulative data, identifies and analyzes potential signals, and communicates data-driven conclusions to internal and external stakeholders.
Perform single case medical assessment, including the determination of seriousness, expectedness/listedness/labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions.
Maintain the timely submission of expedited reports
Support the achievement of the Therapeutic Area's case processing performance timelines. Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution
Identify 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.
Actively participate in Risk Management Committees and other risk management activities for assigned therapeutic areas. Perform product safety reviews as appropriate.
Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness/listedness/labeledness, causality, and data reconciliation.
As appropriate, provide medical safety input, and review or draft sections of response documents to health authority inquiries.
Work with the Therapeutic Area Head and Medical Review Head to proactively and effectively communicate product safety issues and proposed solutions to PSSR management and to the Office of the EU Qualified Person.
Provide timely review of and input to documents, including labeling, protocols, Investigator Brochure, and licensing agreements.
Provide timely input into product related milestones.
Provide medical input, review and analysis of Periodic Safety Update Reports, Expert Statements, Risk Management Plans, and other aggregate reports; where appropriate, draft components of these reports. Ensure accurate, relevant, and meaningful ICSR data and insights.
Provide medical advice and insights to Therapeutic Area colleagues to improve the quality, consistency, accuracy, and clinical relevance of safety reports.
Support PSSR Quality Assurance activities, addressing observations related to medical assessment, as appropriate. Ensure consistency and quality of the medical assessment process.
Provide drug safety support when appropriate to product acquisitions, recalls, and legal issues.
Take responsibility for inspection readiness for medical assessment activities;support regulatory authority inspections when needed.
Proactively communicate with and engage Therapeutic Area colleagues and keystakeholders (e.g., Clinical Development Teams, Regulatory Affairs, Licensing, Manufacturing, and Marketing) to support business objectives and to discuss and resolve safety issues.
Engage internal and external customers with a sense of urgency and an appreciation of their needs and point of view.
As an individual contributor, initiate and/or take a leadership role in projects/process improvements that align with PSSR and/or SER strategic objectives.
Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology) for the assigned product portfolio.
Develop and maintain a comprehensive working knowledge of current regulations governing the processing and reporting of safety data, Standard Operating Procedures, Safety Job Aids, and case processing/coding conventions, consistently completing curriculum training by the specified due dates.
Utilize the corporate performance management process to manage goal setting and individual development. Consistently demonstrate Pfizer Values and Leader Behaviors.
Proactively mentor Therapeutic Area colleagues to foster an environment of trust, understanding, learning, and development.
Manage or contribute to the mentoring and on-boarding of new PSSR colleagues
Medical Degree from an accredited institution
One to two years of experience as an MD in clinical practice
One to two years of relevant experience in pharmacovigilance, clinical research or related field
Pharmaceutical industry experience preferred
Working knowledge of international regulations and guidance documents as related to worldwide reporting requirements, preparation of clinical trial safety assessments, and regulatory submissions including the preparation of aggregate reports
Additional Location Information: New York Headquarters, Peapack, NJ, or Collegeville, PA.
Eligible for Employee Referral Bonus
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.
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A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.