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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