Senior Safety Scientist

At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Creating a more agile and inclusive environment means building a culture where we celebrate innovative thinking. Our Patient Safety team sits within the Chief Medical Office; an integrated, enterprise-wide organisation dedicated to defining the benefit/risk assessment of our medicines across the life-cycle, acquiring and maintaining health authority approvals around the world.

Introduction
The Senior Pharmacovigilance (PV) Scientist role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and other PV Scientists. He/she authors and leads PV input to safety documents and regulatory reports. Senior PV Scientist leads meetings and presents safety data and analyses.


MAIN RESPONSIBILITIES:
• LEADS AND/OR CONDUCTS PROACTIVE PHARMACOVIGILANCE AND RISK MANAGEMENT PLANNING FOR MORE COMPLEX 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.
• LEADS PS ACTIVITIES OF CROSS-FUNCTIONAL PROJECT TEAMS FOR DEVELOPMENTAL COMPOUNDS AND/OR MARKETED PRODUCTS.
• LEADS AND PROVIDES SAFETY EXPERTISE TO INVESTIGATOR BROCHURES, PROTOCOLS, INFORMED CONSENTS AND CLINICAL STUDY REPORTS.
• LEADS THE CROSS-FUNCTIONAL SAFETY STRATEGY AND MANAGEMENT TEAM (SSAMT) FOR LARGE AND/OR COMPLEX PROJECTS.
• PRESENTS COMPLEX ISSUES TO SAFETY INFORMATION REVIEW COMMITTEE (SIRC) AND TAKES THE LEAD ROLE IN DATA EVALUATION AND DISCUSSION OF THE RESULTS WITH THE SIRC CHAIR, GSP AND OTHER KEY STAKEHOLDERS.
• LEADS AND AUTHORS THE REFERENCE SAFETY INFORMATION (RSI) FOR MULTIPLE AND/OR COMPLEX DEVELOPMENT PRODUCTS AND COLLABORATES WITH GSP AND CLINICAL REPRESENTATIVES AS NEEDED
• AUTHORS/PROVIDES STRATEGIC INPUT OR OVERSIGHT FOR MULTIPLE AND/OR COMPLEX PERIODIC REGULATORY DOCUMENTS (PBRERS, PSURS, DSURS) ACCORDING TO THE AGREED PROCESS AND TIMELINES.
• AUTHORS/PROVIDES STRATEGIC LEADERSHIP TO REGULATORY SUBMISSIONS FOR NEW PRODUCTS, FORMULATIONS OR INDICATIONS (NDA/BLA, MAA), IN PARTNERSHIP WITH THE GSP AND OTHER FUNCTIONAL EXPERTS.
• TRAINS AND MENTORS JUNIOR MEMBERS OF THE TEAM, E.G. IN APPROVED PV PROCESSES, ANALYTIC METHODOLOGIES, ETC.

REQUIREMENTS – EDUCATION AND EXPERIENCE
• A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
• Fluent in written and verbal English
• Advanced knowledge of PV regulations
• Intermediate understanding of epidemiology, preferred

ABOUT ALTEN

At Alten we develop and deliver competence for world-leading companies through the most committed engineering and IT consultants. Our customers are in industries such as Energy, Telecom, Automotive, Defense & Aerospace, Life Science and Industry, and we are active throughout the product chain. As part of the Alten Group, we have over 35.000 employees and operations in 25 countries. It is our conviction that real commitment is created through the choice and the opportunity to influence their own personal development - our business model gives that opportunity. This choice allows us to offer our customers the most committed consultants, regardless of assignments

The selection process is ongoing and we are looking forward to your application!