PFIZER
Manager - Clinical Pharmacology,
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.
QUALIFICATIONS
Bachelor’s
or Master’s, or an equivalent degree in Pharmacy, Pharmacology, or related
disciplines
Industry
experience of at least 7-8 years for Bachelor’s degree or 5-6 years for
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.
TO APPLY
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