Drug Safety Specialist, Novartis, Norway

Job description

Job Description

The purpose of the Drug Safety Specialist role is to support team, representation, and responsibility for handling pharmaco-devicevigilance of Novartis marketed and investigational products (drug and devices) from all sources within agreed timeframes, high quality standard and in compliance with the global and local Novartis Patient Safety (NPS) standard operating procedures and local regulatory requirements. Pharmacovigilance is the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products and medical devices.

You will be a part of a Nordic Patient Safety organization with 22 highly engaged employees and you will get the opportunity to work in a dynamic department with great colleagues and opportunities for professional and personal development. We are a good team with high dedication, openness and informal environment

Key Responsibilities:
As a Drug Safety Specialist you will;
Evaluate, coordinate, and /or manage the collection, documentation, triage, translation (if applicable) processing in Novartis Safety Database, transferring to Central Processing sites, follow-up, submission/distribution to local health authorities and archiving of all safety reports for all Novartis products (drugs and devices) from pre and post-authorization (as applicable) phase according to the defined timelines and quality parameters.
• Determine the necessity for follow-up and prepare and / or perform follow-up of adverse event reports as required by local SOP and guidance documents or by direction of designated parties. (Medical function, Health Authorities, etc.)
• Perform submission of individual case reports to local Health Authority
• Play an active/leading role in cross-functional teams on safety matters/NPS special projects.
• Conduct training and provide mentoring of team members and other line functions/business units and vendors (e.g. Clinical research, DRA, sales, consumer interaction,,etc).
• Represent NPS at internal and external meetings
• 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
• Acts as DSR Deputy: *functional (in terms of responsibility for PV system) and operational (in terms of managing the NPS Team).

About Novartis:
Novartis is a global healthcare company based in Switzerland that provides solutions to ad-dress 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’

Desired profile

Minimum requirements

The ideal candidate will have:
• A degree within natural science (i.e. biology, chemistry, medicine or pharmacy)
• Intermediate/fluent knowledge of English (oral and written) and local/Nordic language
• Preferably 1 year experience in drug safety / Development or closely related areas of responsibility, but we also encourage newly graduated individuals to apply
• Ability to lead and deliver initiatives.
• Attention to detail and quality focused
• Good organizational, planning and prioritizing skills

Novartis is an equal opportunities employer and welcome applications from all suit-ably 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.