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Team Lead Aggregate Reports


Austin, TX 78728
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Job Details

The PSSR Aggregate Reports Team Lead provides the strategic direction and oversight of processes, colleagues and vendors/contractors responsible for the preparation of regulatory documents. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, NDA Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc.), responses to regulatory queries on safety topics, post-marketing safety assessments, Risk Management Plans and relevant documents, and other documents in support of content of the safety labels updates. Delivery of some of these documents may be by matrix management of, or collaboration with, other analysts, epidemiologists, physicians and authors in safety or Worldwide Development. The SER PSSR Aggregate Reports Team Lead ensures that the staff within his/her line are appropriately managed such that, for the assigned projects, high quality documentation compatible with internal and external requirements and regulations and are prepared in a timely fashion to support business needs.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.
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