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 : Clinical Pharmacology Lead
Job Description
Role Summary
• Serves as the Clinical Pharmacology representative on assigned studies.
• Provides Clinical Pharmacology support for product defense and maintenance activities for addressing regulatory queries and labeling needs.
• Implements the use of Modeling and Simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, and patient characteristics for pediatric development, new indications, and product defense.
ROLE RESPONSIBILITIES
• Provides clinical pharmacology support on multi-disciplinary study teams for Global Brands, Sterile Injectables, post-approval commitments, and global BA/BE studies.
• Provides clinical pharmacology components at study level (including protocol preparation, clinical conduct, and reporting).
• Responsible for interfacing with partner lines (e.g. clinical assay group, statistics, pharmacometrics) to ensure appropriate support for assigned programs and studies
• Assures that the clinical pharmacology strategy serves the overall objectives of the clinical program and is designed and executed to the highest scientific standards and delivers the data required to fulfill regulatory requirements.
• Influences environment outside of Pfizer through methods such as publication and presentations.
• Responsible for addressing, writing and reviewing regulatory queries and labeling requests to support maintenance.
Candidate Profile
• Master’s or PhD in Pharmacy or Pharmaceutical Sciences or related disciplies
• At least 6-8 years of drug development experience with at least 3 years in clinical pharmacology or preclinical PK and drug metabolism.
• Experience in interactions with regulatory agencies
• Organizational awareness (inter-relationship of departments, business priorities, etc.)
Additional Information
Qualification : Ph.D, M.Pharm, M.Sc
Location : Chennai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical
End Date : 5th August, 2019
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