Manager, Patient Safety Scientist

About the role

AstraZeneca is looking for a Manager, Patient Safety Scientist in Barcelona, Spain. This is an entry-level role supporting the Global Safety Physician (GSP) and the (Senior/Principal) PV Scientist in reviewing safety data and related documents to identify and escalate potential safety issues. It also involves drafting first versions of safety documents and regulatory reports and taking part in meetings as needed. The position is based in Barcelona with 3 days working from the office and 2 days working from home.

Key responsibilities

• Support proactive pharmacovigilance and risk management planning for designated products, including preparing the safety aspects of global Risk Management Plans with the GSP and PV Scientist.
• Provide patient safety input to pivotal study documents such as Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Run and support routine signal detection processes for all products in the area of responsibility, using database searches to find relevant data.
• Create first drafts of documents with clear conclusions in response to internal or regulatory authority requests for safety data.
• In consultation with the GSP and clinical representatives, draft the Reference Safety Information (RSI) for assigned development products, coordinate meetings and track timelines.
• Provide input to periodic regulatory documents (PBRERs, PSURs, DSURs) and to global regulatory submissions for new products, formulations or indications (NDA, BLA, MAA).
• Raise concerns and issues to senior staff in a timely manner.

Required profile

• Life sciences, pharmacy or nursing degree.
• Advanced knowledge and experience in Patient Safety and/or Clinical/Drug Development.
• Fluent written and spoken English.
• Awareness of pharmacovigilance regulations.
• MD, MSc/PhD in a scientific discipline.