Novartis Patient Safety Specialist

Job description

Job Description

Job Purpose:
The purpose of the Patient Safety Specialist role is to play an active role in the collection, detection, assessment, monitoring, and prevention of adverse effects from marketed and investigational pharmaceutical products (pharmacovigilance), and medical devices (device vigilance), working closely together with the local team. The emphasis is on quality and timeliness, and we are following the global and local Novartis Patient Safety (NPS) standard operating procedures as well as local and European regulatory requirements, in order to ensure the safety of our patients.

You will be a part of a Nordic Patient Safety organization, with highly engaged employees collaborating across country borders, and you will get the opportunity to work in a dynamic environment with great colleagues and opportunities for personal and professional development. The Swedish Patient Safety team is located in Täby, Stockholm, and consists of four people. Our work environment is characterized by openness and a strong team spirit.
This is a temporary position for 12 months.

Key Responsibilities:
• Manage the collection, triage and processing of adverse event reports for all marketed and investigational Novartis drugs and devices in the Novartis Safety Database (Argus Affiliate). This process includes tasks such as transcribing, translating and entering data from source documents into the safety system, as well as transferring high quality reports to Novartis Central Processing sites within regulatory timeliness.
• Work in close cooperation with other local and global Patient Safety associates in order to ensure accurate evaluation of safety data.
• Determine the necessity for follow-up of adverse event reports and prepare and/or perform follow-up of adverse event reports with patients and healthcare professionals, in order to obtain a complete case report of high standard.
• Prepare and submit Key Performance Index (KPI) reports in a timely manner.
• Manage and maintain an efficient physical Patient Safety archiving system (internal and external).
• Cooperate with internal departments and external stakeholders (e.g. Medical Information, Quality Assurance and third-party contractor, if applicable) in order to ensure that all Safety data has been exchanged between the parties, for example by performing periodic reconciliations
• Develop, update and implement local procedures and training materials
• Conduct training and provide mentoring of team members and other line functions/business units and vendors (e.g. clinical research, regulatory affairs, sales, etc.).
• Represent Novartis Patient Safety at internal and external meetings.
• Play an active role in cross-functional teams on Safety matters.
• Provide input, review and approval of program/study proposals from other functions, in order to establish the necessary controls on collection and reporting of adverse event information.
• Provide support for any internal or external pharmacovigilance audits and support (if applicable) and in the implementation of any corrective/preventative action as determined by auditors/ inspectors

About Novartis:
Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. In Novartis Group we focus on three areas – innovative medicines (Pharmaceuticals & Oncology), eye care (Alcon) and generics (Sandoz). We have offices in all four Nordic countries and we are approximately 900 associates.
Our mission is to discover new ways to improve and extend people's lives. Our vision is to be a trusted leader in changing the practice of medicine. Corporate responsibility is central to how we run our business. We focus our CR work in two key areas: expanding access to healthcare and doing business responsibly.
As a global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.

Diversity and Inclusion
Each of us is different. At Novartis, we aspire to move beyond stereotypes, assumptions and bias to bring these differences together every day. To operate successfully as a global organization, it is essential that our people reflect the rich cultural, ethnic and gender diversity of our markets. Diversity of our workforce enhances customer insight and our ability to meet the needs of patients and other stakeholders. Retaining the most qualified talent adds value to our company, our customers, our employees, our shareholders, our suppliers and the communities in which we live and work.

Culture and Values
Novartis has a clear mission, focused strategy and strong culture, all of which we expect will support the creation of value over the long term for our company, our shareholders and society. We recognize that our business depends on the creativity, dedication and performance of our associates. We encourage associates to focus on achievement through collaboration and innovation. Our values help guide the choices people make every day, and they define our culture and help us execute the Novartis strategy in line with our mission and vision.

Our values and behaviors are:
Innovation - by experimenting and delivering solutions
Quality - by taking pride in doing ordinary things extraordinarily well
Collaboration - by championing high performing teams with diversity and inclusion
Performance - by prioritizing and making things happen with urgency
Courage - by speaking up, giving and receiving feedback
Integrity - by advocating and applying high ethical standards every day

Benefits of Working for Novartis:
• Competitive Salary
• Bonus Scheme for employees on all levels
• Pension & Insurance Scheme
• “Be Healthy” initiatives to promote associate health and prevent future health issues
• Flexible working hours and possibility to work from home

‘I came for the job, I stay for the culture’
Position Title

Novartis Patient Safety Specialist

Desired profile

Minimum requirements

The ideal candidate will have:
• An Education/Degree within natural sciences (i.e. biology, chemistry, medicine or pharmacy)
• Excellent communication skills and fluent knowledge of working English (oral and written) and Swedish (knowledge of an additional Nordic language is beneficial, but not a requirement
• Preferably 1 year of work experience in the pharmaceutical industry (experience within Patient Safety, Quality Assurance, Regulatory or related areas is beneficial), however we also encourage newly graduated individuals to apply
• Ability to lead and deliver initiatives.
• Good organizational, planning and prioritizing skills, with high emphasis on quality

Novartis is an equal opportunities employer and welcome applications from all suitably qualified persons.

We kindly ask you to apply with an English version of your CV and if shortlisted you can expect a call from an international number. Deadline for the applications is 17th of June, 2018.
Job Type

Full Time
Country

Sweden
Work Location

Stockholm
Functional Area

Research & Development
Division

Global Drug Development
Business Unit

CMO & PATIENT SAFETY GDD
Employment Type

Temporary
Company/Legal Entity

NOV SVERIGE SWE