Important Pharmaceutical Company is looking for a Patient Safety Lead.
Responsibilities:
Lead the strategy for proactive PV and risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the Global Safety Physician and others as required.Lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization.Perform duties as Safety Strategy and Management Team Leader for complex and/or multiple products.Lead presentation of intricate issues to Safety Information Review Committee.Lead safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.Lead safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA) with the GSP and other functional specialists.Handle negotiations and provide expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.Take accountability and lead resolution of safety issues and mediate cross-functional agreement.Participate in due diligence activities.Provide training and mentorship to new GSPs and PV Scientists in approved processes and systems. Requirements:
A degree in life sciences (or similar field) and advanced Patient Safety and/or Clinical/Drug Development experience.PharmD/MSc/PhD in scientific field is a plus!Excellent written and verbal English.Advanced knowledge of PV regulations.Clinical Development (Early and/or Late Phase).Post-Marketing surveillance.MAA/BLA Submissions.Periodic Reports.Risk Management Plans (from scratch).Governance Board Interactions. Location: Barcelona, Spain.
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