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 : Manager - Clinical Pharmacology
Job Description
Role Summary
• Serves as the Clinical Pharmacology representative on assigned bioavailability (BA) and bioequivalence (BE) studies needed for global submissions.
• Provides Clinical Pharmacology support for product defense and maintenance activities for addressing regulatory queries and labeling needs.
ROLE RESPONSIBILITIES
Product Maintenance and Defense Responsibilities
• Responsible for conducting literature searches, writing regulatory queries and labeling requests to support defense and maintenance of PEH products.
• Represents Clinical Pharmacology on teams such as Labeling Teams related to Product Maintenance and Defense.
• Providing technical and non-technical QCs of documents required for regulatory submission, including regulatory responses.
• Provides clinical pharmacology support for various regulatory interactions.
BA/BE Study Responsibilities
• Works with multifunctional study team to design, conduct and report the assigned clinical pharmacology studies ensuring that all processes and activities are fully aligned with Pfizer SOPs, guidelines and regulatory requirements.
• Responsible for interfacing with partner lines (e.g. clinical assay group, statistics, pharmacometrics, clinical) to ensure appropriate support for assigned studies.
Candidate Profile
• Bachelor’s or Master’s, or an equivalent degree in Pharmacy, Pharmacology, or related disciplines
• Industry experience of at least 5 years for Bachelor’s degree or 3 years for Master’s degree preferred
• Strong teamwork and the ability to work effectively in a matrix environment.
Additional Information
Qualification : M.Pharm, B.Pharm
Location : Chennai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical Pharmacology
End Date : 15th August, 2019
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