Senior Patient Safety Scientist Vaccines&immune
hace 2 semanas
Important Pharmaceutical company is looking for a Senior Patient Safety Scientist Vaccines&Immune Therapies to incorporate in Barcelona.
Essential Requirements
A Bachelor’s in sciences/pharmacy/nursing degree or related field with a minimum of 3 years of experience or an advanced degree with 2 plus years of relevant experience
Patient Safety and/or Clinical/Drug Development demonstrable experience working in safety &/or scientific activities in at least 3 of the following areas:
**Clinical drug development (Early and/or Late Phase**: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning)
Post-Marketing Surveillance (including signal detection & evaluation)
MAA/BLA submissions (preparation and authoring of the safety related aspects of the Common Technical Document)
Periodic Safety Reports (deliver strategy, preparation and authoring)
Risk Management Plans (deliver strategy, preparation and authoring)
Governance board interactions and communication across a range of activities
Good knowledge of PV regulations
Demonstrated ability to handle more than one activity simultaneously, prioritizing well and recognizing key issues
Ability to work effectively in an advanced matrix structure
Fluent in written and verbal English
Preferred Requirements
MSc/PhD/PharmD in scientific discipline
Understanding of epidemiology
CV's English Only
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