Clinical Pharmacology Lead Vacancy 2019 @ Pfizer
Pharma Lead. Manager Post vacant @ Pfizer. Pfizer 2019 Jobs, Pfizer Medical jobs, Pharmaceutical Science jobs 2019. Pfizer hiring M Pharma candidates for a Sr. Specialist vacancy. Interested and eligible candidate can Apply for this post. Check out all the details on Rasayanika.com
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
Job Id: 4754526
Location: India – Chennai
Job Title: Clinical Pharmacology Lead
No.of posts: 01
Eligibility: Master’s or Ph.D. in Pharmacy or Pharmaceutical Sciences or related disciplines
- 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.)
• 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 the knowledge of pharmacokinetics, pharmacodynamics, and patient characteristics for pediatric development, new indications, and product defense.
Roles & 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.
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