Manager, Patient Safety Scientist

AstraZeneca plc; Barcelona; Hybrid; EUR 42,000 - 56,000; Full time

Job summary

AstraZeneca plc in Barcelona is seeking an entry-level Manager, Patient Safety Scientist to support the Global Safety Physician and PV Scientists with safety data reviews and document drafts.

You will participate in meetings and help prepare safety documents, RSI drafts, and regulatory submissions. Fluent English and pharmacovigilance knowledge are required; MD/MSc/PhD is preferred. This hybrid role combines 3 days in the office with 2 days from home.

Qualifications

• Life sciences or pharmacy/nursing degree required.
• Advanced Patient Safety or Clinical/Drug Development knowledge.
• Fluent in written and verbal English.
• MD, MSc/PhD in scientific discipline preferred.

Responsibilities

• Supports proactive pharmacovigilance and risk management planning for designated products, including project managing preparation of the safety aspects of global Risk Management Plans.
• Provides patient safety input to pivotal study documents (IBs, Protocols, Informed Consents, CSR).
• Runs/supports routine signal detection processes with the GSP.
• Identifies and uses sources to retrieve data for signal evaluation; drafts clear safety conclusions for internal or regulatory requests.
• Drafts RSI for assigned products; coordinates meetings to track timelines and support regulatory submissions.
• Provides input to global regulatory submissions (NDA, BLA, MAA) in liaison with GSP and PV Scientists.
• Raises concerns to senior staff in a timely manner.

Skills

Fluent English

Pharmacovigilance knowledge

Education

Life sciences/pharmacy/nursing degree

MD, MSc/PhD in scientific discipline

Job description

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction

The Manager, Patient Safety Scientist is an entry level role which supports the Global Safety Physician (GSP) and (Senior/Principal) PV Scientist with the review of safety data and related documents to identify and escalation potential safety issues. He/she has the ability to provide the first draft of safety documents and regulatory reports, and will participate in meetings, as necessary.

Main Responsibilities

• Supports proactive pharmacovigilance and risk management planning for designated products, including project managing preparation of the safety aspects of the global Risk Management Plans, in partnership with the Global Safety Physician (GSP) and (Senior/Principal) PV Scientist, as appropriate.
• Provides patient safety input to pivotal study documents, for example Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Runs/supports routine signal detection processes in partnership with the GSP, for all products in area of responsibility.
• Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals. Creates first draft of documents with clear conclusions in response to internal or regulatory authority requests for safety data.
• In consultation with the GSP and Clinical representatives, drafts the Reference Safety Information (RSI) for assigned development products; coordinates meetings and tracks timelines to ensure completion. Provides input to periodic regulatory documents (e.g. PBRERs, PSURs, and DSURs) according to the agreed processes and timelines.
• Provides patient safety input to the global regulatory submissions for new products, formulations or indications (e.g. NDA, BLA, MAA), in partnership with GSP and (Senior/Principal) PV Scientist and in liaison with other functional experts.
• Raises appropriate concerns/issues to senior staff in a timely manner.

Education and Experience

• A life sciences/pharmacy/nursing degree, and advanced Patient Safety and/or Clinical/ Drug Development knowledge and experience.
• Fluent in written and verbal English
• Awareness of Pharmacovigilance regulations
• MD, MSc/PhD in scientific discipline

Date Posted

09-nov-2026

Closing Date

11-nov-2026

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.