Manager Clinical Pharmacology Job Vacancy @ Pfizer
Manager Clinical Pharmacology Job Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Pfizer invites pharmaceutical science candidates for the post of officer. Check out all the details on the same below:
Job Title: Manager
Eligibility:
- Bachelor’s or Master’s, or an equivalent degree in Pharmacy, Pharmacology, or related disciplines
- Industry experience of at least 7-8 years for a Bachelor’s degree or 5-6 years for a Master’s degree preferred
- 3 – 5 years of experience after PhD in relevant field
- Strong teamwork and the ability to work effectively in a matrix environment.
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 the 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.
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