Piramal Enterprises Limited -
NCE research unit focuses on the discovery and development of new drugs
to treat unmet medical needs in the areas of cancer, metabolic
disorders, inflammation and infectious diseases. The Company's focused
and well defined business strategy has enabled it to successfully
identify promising candidates and build a robust pipeline of molecules
at various stages of preclinical and clinical development. Piramal
Enterprises intends to harness India's skills in research based
activities to develop products which will be marketed and sold worldwide
either independently or through collaboration with leading
pharmaceutical companies. NCE Research is committed to widening its
pipeline through in-licensing and research collaborations, and currently
has partnerships with leading global pharmaceutical companies including
Eli Lilly and Merck, and premier institutes in India and abroad.
Designation: Quality Assurance - Senior Manager
Job Description:
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Will be responsible for setting up of systems in Pharrnacovigilance along with PV functional team
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Will be responsible for OCP OA activities in clinical
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Will be responsible for SOP review and management for PV and OCP
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Will be responsible for periodic audits (process based and system based audits) of PV and OCP
- Will be responsible for PV and OCP trainings.
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Should have a strong background in Clinical and
Pharmacovigilance Quality Assurance Should be well versed with quality
management systems for CCP and PV Should be well versed with guidelines
(ICH OCP. Schedule V).
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Should have experience in conduct of PV and OCP audits.
- Should be well versed with PV systems, requirements and guidelines (Vol. A, FDA, MHRA guidelines. Schedule Y PV requirements) and support in setting up PV systems.
- Should be open for travelling (moderately).
- Excellent verbal communication skills and interpersonal skills are required along with strong leadership, organizational and planning skills together with scientific creativity and critical thinking.
Education: B.pharm/M.pharm/M.Sc Lifescience.
Experience : Atleast 7-8 years experience in field of clinical QA.How to apply:
Interested candidates can mail their CV to research.recruitment@
