...Job Description
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials...
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Worldwide
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3 days per week
Position Summary:
Reporting to the SVP, Head of Clinical Safety & Postmarketing Pharmacovigilance, the Executive Director, Postmarketing Pharmacovigilance & Compliance will play a key role in management of the Pharmacovigilance System Master File (PSMF), including Compliance...
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...Development (medical ICSR discussion and follow-up, as well as safety surveillance). The role supports regulatory compliance with pharmacovigilance regulations, safety signal detection/management, and contributes to the overall benefit-risk management of Exelixis products....
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...medical documentarian.
Experience
At least 1 year of medical/surgical nursing or a similar setting and 1 year of experience in pharmacovigilance, or equivalent setting. Global pharmacovigilance database knowledge is preferred along with proficient knowledge of global...
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Reporting to the Associate Director, Postmarketing Pharmacovigilance or higher, the Senior Manager, Postmarketing Pharmacovigilance will play a key role in supporting the safety assessment, evaluation, and risk management of products in the postmarketing setting, including...
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Worldwide
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Reporting to the SVP, Head of Clinical Safety & Postmarketing Pharmacovigilance, the Executive Director, Postmarketing Pharmacovigilance & Compliance will play a key role in management of the Pharmacovigilance System Master File (PSMF), including Compliance and Inspection...
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Full time
Local area
Flexible hours
...Management (GSSRM), the Chief Safety Officer (CSO), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory...
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...internal product training for other Airgas Therapeutics personnel, including the commercial and production teams.
Gather any pharmacovigilance or product complaints from customers and report to Regulatory. Assist in complaint/ adverse event investigations, implementing...
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...Accountabilities:
1. Support the SVP, Head of GSPV in creating enterprise level mid- to long-term strategy in all sub-functions of Pharmacovigilance (PV) including Innovation, Medical Safety, Safety Science such as signal detection, PV Operations and data analytics, PV...
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Summer work
Worldwide
...safety activities, including rapid analytics for signal strengthening and formal required/committed evaluation studies, as part of Pharmacovigilance and Risk Management Plans.
+ Be involved in supporting efforts for the Office of the Chief Medical Officer and cross-sector...
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2024 Summer R&D Pharmacovigilance AI Internship
CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency...
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Summer work
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...program strategy and development plan, scientifically sound, feasible to execute, efficient and in line with Good Clinical and Good Pharmacovigilance Practice (GCP and GPvP).
+ Ensure excellent understanding of the external dynamics in medical practice, policy, regulatory...
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...services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major offices across US, China, Europe, India, Japan, and the Philippines with over 2,400...
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