Medical Device Safety Medical Writer, Global Pharmacovigilance

Ferring Pharmaceuticals A/S

Fuldtidsjob
Storkøbenhavn

Medical Device Safety Medical Writer, Global Pharmacovigilance


Job Title:

Medical Device Safety Medical Writer, Global PharmacovigilanceJob Description:

Driven by research and a passion for science, Ferring Pharmaceuticals is a biopharmaceutical company dedicated to the development of innovative treatments that make a real difference in people’s lives all over the world. Active in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics, we develop medicine on the body's own terms. We believe in the power of people and research - and go where ideas and research take us.

Would you like to be part of a newly established team responsible for vigilance reporting on medical devices as well as preparing all authority required reports for Ferring medical devices? Do you thrive when able to influence processes and ways of working?

We are looking for a permanent Safety Medical Writer for medical devices with good drive and positive energy.

THE DEPARTMENT

In Global Pharmacovigilance (GPV) we are close to 70 international employees responsible for the surveillance of Ferring’s medicinal products and devices. The Safety Surveillance function in GPV is divided into three teams concerning medicinal products and a smaller matrix team dealing with medical devices reporting directly to the Senior Director of Safety Surveillance.

The matrix medical device team currently consists of 4 people and the work in our department is carried out in the mindset of the Ferring Philosophy; trust, integrity, commitment and openness.

THE JOB

As a Medical Device Safety Medical Writer, you will primarily be responsible for coordinating, planning and preparing CEP´s and CER´s, giving input to risk management files as well as to clinical questions. When the new MDR legislation is fully enforced during 2020, the work will also encompass writing PSUR´s/Post Market Surveillance Reports and Post Market Surveillance Plans on Ferring medical devices.

Further, the role includes preparing and analysing the data included in these documents. Other tasks include co-ordinating and preparing answers to requests from competent authorities, being involved in preparing vigilance input for the labelling process and supporting the improvement of our Standard Operating Procedures and Working Instructions.

You will be collaborating closely with other GPV staff including members of the Monitoring and Analysis, Safety Medical Writer and Risk Management teams. You will also be required to collaborate with internal Ferring stakeholders from other departments.

QUALIFICATIONS

The successful candidate is experienced within clinical, vigilance/safety medical writing and has prepared a significant number of reports. Good communication and planning skills are essential as are English language skills.

As a person you are highly motivated, self-driven and a team player. You are flexible, supportive, detail- and action-oriented and keen on working in an international, multi-cultural corporate environment.

The preferred candidate has a scientific degree e.g. MSc Pharm., MSc Human Biology or MD. and at least two years of experience from the medical device industry. Experience in writing CER´s is mandatory. Seniority will be assessed based on the candidate’s qualifications.

ADDITIONAL INFORMATION

Further information about the position can be obtained by contacting Pernille Hjarnaa, Senior Director, Safety Surveillance, Global Pharmacovigilance (pehj@ferring.com). Your application and CV in English should be sent as soon as possible but no later than 03-Jan-2020
, as we will be reviewing incoming applications on an on-going basis.

Location:

Ferring Denmark


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Fuldtidsjob
Storkøbenhavn
Medicinal & Sundhed
Forskning & Udvikling
Medicinal & Sundhed
Naturvidenskab



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https://jobbank.dk/job/1427854/