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Manager, Patient Safety Scientist

Location Bengaluru, Karnataka, India Job ID R-138766 Date posted 18/05/2022

JOB TITLE : MANAGER, PATIENT SAFETY SCIENTIST

CAREER LEVEL: D

Leverage technology to impact patients and ultimately save lives

Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you!

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work.

ABOUT OUR IT TEAM

It’s a dynamic and results-oriented environment to work in – but that’s why we like it. There are countless opportunities to learn and grow, whether that’s exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross- functionally and broadly together.

ABOUT THE ROLE

Manager, Patient Safety Scientist should lead scientific, technical or Patient Safety input for a product, group of products, systems or processes. They has the ability to provide authoring and PV input to safety documents and regulatory reports. Manager, Patient Safety Scientist also has the ability to lead meetings and present safety data and analyses

Accountabilities/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 complex products

  • Should be able to perform end to end Pharmacovigilance activity independently on 2 or more established 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 9 to 11 years of experience

Skills and Capabilities

The role holder will have:

  • Ability to work effectively as a member of a cross-functional or distributed team

  • Ability to work with autonomy

  • Ability to acquire and assimilate knowledge in different fields, 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

WHY JOIN US ?

We’re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.

We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we do matters.

SO, WHAT’S NEXT?

Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.



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 authorisation and employment eligibility verification requirements.

50056680 D CDSU R&D Oncology (Susan Galbraith (07016555)) (85008610)

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.