Location: Barcelona - Spain (3 days working from the office and 2 days working from home)
Introduction:
TheAssociate Director, Patient Safety Scientistrole works collaboratively with the Global Safety Physician (GSP) and (Senior/Principal) PV Scientist with the review of safety data and related documents for potential safety issues. He/shehas the ability toprovide authoring and PV input to safety documents and regulatory reports.Associate Director, Patient Safety Scientistalso has the ability tolead meetings and present safety data and analyses.
Main Responsibilities:
Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects ofGlobal Risk Management Plans, in partnership with the GSPand others as appropriate
RepresentsPS on cross-functional project teams for developmental compounds and/or marketed products.
Has the ability topresent safety information atexternalmeetings.
Has the ability toperform duties as a Safety Strategy and Management Team (SSaMT) leader for smaller or less complex projects.
Presentsissues to Safety Information Review Committee (SIRC) andhas the capacity totake the lead role in data evaluation and discussion of the results with theSIRCChair, GSP and other key stakeholders.
Producesaccurateand fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
Collaborates with GSP and Clinical representatives and authors theReference Safety Information (RSI)for assigned development products; coordinates meetings and tracks timelines to ensure completion
Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies,literatureand other information sources toestablishthe safety profile of drugs and manage the risk to patients.
Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
Authors/providesstrategic inputto regulatorysubmissions for new products,formulationsor indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
Contributes to the PScomponentof contracts/agreements with third parties to ensure quality and integrity of agreement.
Trains junior members of the team in PS tools and systems.
Requirements – Education and Experience
A life sciences/pharmacy/nursingdegree,anddemonstrated Patient Safety and/or Clinical/ Drug Development experience.
Intermediate knowledge of PV regulations
Fluent in written and verbal English
MD,MSc/PhD in scientific discipline, preferred
Basic understanding of epidemiology data, preferred
Date Posted
17-jul-2026
Closing Date
30-jul-2026
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