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Pfizer looking for Team Lead Aggregate Reports

 

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Founded in 1849, 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 both people and animals. 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.

Post : Team Lead Aggregate Reports

Job Description
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.

 

Additional Information:
Location: Chennai Device - Hospira
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Team Lead

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