Director, Principal Patient Safety Scientist

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

Introduction:

The Director, Principal Patient Safety Scientist role provides expertise to multiple and/or single but complex products in different stages of development as needed. He/she provides oversight of safety documents and deliverables for these projects in collaboration with the Global Safety Physician (GSP) and other PV Scientists. He/she leads PV strategy for safety documents and regulatory reports.

Main Responsibilities:

• Leads the strategy for proactive pharmacovigilance 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 GSP and others as appropriate.

• Provides subject matter expertise in the therapeutic area and across multiple products.

• Has the ability to lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization.

• Performs duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products.

• As a Safety expert leads presentation of complex issues to Safety Information Review Committee (SIRC).

• Leads safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.

• Leads safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.

• Leads negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.

• Takes accountability and leads resolution of complex safety issues and mediates cross-functional agreement.

• Has the ability to participate in due diligence activities.

• As a safety expert, provides training and mentorship to new GSPs and PV Scientists in approved processes and systems.

Requirements – Education and Experience

• A life sciences/pharmacy/nursing degree, and advanced Patient Safety and/or Clinical/ Drug Development experience

• Fluent in written and verbal English

• Advanced knowledge of PV regulations

• MD/MSc/PhD in scientific discipline, preferred

• Advanced understanding of epidemiology, preferred

Date Posted

Closing Date

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.