Manager, Senior Patient Safety Scientist

Job Title: Manager, Senior Patient Safety Scientist

Career Level - D

Introduction:

The Manager, Senior Safety Scientist works collaboratively with Global Safety Physician (GSP) and SSaMTL or as a SSaMTL should lead scientific, technical or Patient Safety input for a product, group of products, systems or processes. He/she has the ability to provide authoring and PV input to safety documents and regulatory reports. Manager, Senior  Safety Scientist  also has the ability to lead meetings and present safety data and analyses

Main Responsibilities:

• Perform all Surveillance activities including periodic report production, leading monthly signal-detection activities and SIRC activities for established products.
• Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Able to produce of high-quality and timely responses to safety queries
• Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals for all products in area of responsibility.
• Support a performance-driven culture
• Raises appropriate concerns/issues to senior staff in a timely manner.
• Safety Strategy and Management Team (SSaMT) leader for slightly more complex products
• Should be able to perform end to end Pharmacovigilance activity independently on the assigned products and should mentor others within their role.

• Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures

• Compliance with relevant procedural documents provide strategic & scientific input into regulatory authority submissions, queries, and discussions
• Support response to queries/impositions by regulators, with high level of attention to implications in other countries
• Ensure good communication and guidance to AZ products
• Liaise effectively and maintain excellent relationship with external contacts

Minimum Requirements –Education and Experience

• Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety/clinical development
• Comprehensive understanding of applicable Patient Safety regulatory obligations in EU

• Awareness of Patient Safety policies, processes and procedures

• Awareness of medico-legal aspects of patient safety
• 6 to 9 years Patient Safety experience (with clear evidence of delivery)

Total of 10 to 12 years of experience

Skills and Capabilities

The role holder will have:

• Ability to work effectively as a member of a cross-functional or global team
• Ability to work with autonomy

• Ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
• Good communication skills with ability to work across cultures
• High ethical standards, including a commitment to AstraZeneca values and behaviors
• Ability to appreciate diversity and work as equals with global and cross-functional teams

Communication:

The role holder will have:

• Well-developed interpersonal skills
• Cultural sensitivity
• Ability to network with other functions globally

Internal and External Contacts/Customers

• Patient Safety personnel at all levels
• Regulatory Affairs and other AstraZeneca personnel

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.