Vigilance Associate – Medical Device
Q-Med Q-Med / Biomedicinjobb / Uppsala
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Q-Med develops innovative products for aesthetic, corrective and hospital use. In the aesthetic field, Q-Med offers safe, effective and innovative solutions to preserve restore and maintain a healthy and beautiful skin through a complete product portfolio including Emervel, Restylane, Macrolane and Azzalure/Dysport. In March 2011 Q-Med became part of Galderma. Today, the company has over 4 000 employees in 31 affiliates around the world. The state-of-the-art laboratories in France and Sweden together with 4 manufacturing sites are dedicated exclusively to meeting the needs of dermatology patients and physicians. Galderma is present in more than 70 countries throughout the world.
Q-Med is a global leader in aesthetic and corrective treatments. With global headquarters in Uppsala (Sweden), Q-Med is a division of Galderma, one of the world’s leading dermatology companies.
The Safety and Risk Management group is responsible for all Medical Device Vigilance and safety risk management activities, including evaluation, trending and signal detection from post market complaint reports and in clinical studies.
We are expanding and now looking for a Vigilance Associate to work with vigilance activities for the medical device product line. You will report to the Head of Safety and Risk Management at the Medical Affairs department.
About the job
We are looking for an experienced vigilance professional to work with post-marketing activities and investigational products, including adverse event case processing and ad hoc safety reporting of regulatory documents and routine Medical Device Vigilance.
You will be responsible for:
• Collecting, data entering, and processing medical complaints in compliance with Medical Device Vigilance Regulations.
• Working cross functionally with medical, vigilance and regulatory functions at global or local levels for distributing adverse incident reports, handling information queries, and compilation of required regulatory safety summary reports.
• Handling and reporting serious adverse events (SAEs) in clinical studies.
• Contributing to design and contents of the safety related documents and case report forms for clinical trials in collaboration with the clinical study team.
• Vigilance database reconciliation activities in clinical studies and with external partners.
About you
• You have a University degree within the biomedical science, pharmacy or health sciences.
• You bring some relevant vigilance-related experience from the pharmaceutical industry, preferably from the Medical Device area. You have some knowledge of the post marketing vigilance regulations; knowledge of clinical study adverse event handling is meriting.
• You have substantial computer proficiency with standard software programs and good general computer literacy. Previous experience from a drug or device safety system environment and MedDRA coding is meriting.
• You are flexible, methodical, and detail-oriented with the ability to prioritize and deliver against strict time frames.
• You possess the ability to work with individuals at remote locations and ability to seek a specialist advice if necessary.
• You possess good communication skills in English and Swedish, both verbal and written.
• We can offer you a role in a very dynamic and exciting work environment and growing business with many local and international contacts.
For further questions please contact:
Christer Atuma, Head of Safety and Risk Management: 0733-871434
Apply for this position as soon as possible though no later than February 18, 2013.
Welcome with your application!
We ask advertising companies or recruitment agencies not to contact us for this recruitment.
Q-Med does not accept unsolicited resumes from staffing companies, including recruitment agencies and / or head hunting companies. Q-Med has a list of preferred partners and pays no fees to companies without a signed agreement. Any recruiter, person or organization that submits a resume to this career site or directly to Q-Med does so with knowledge that the candidate's CV becomes Q-Med’s property. Q-Med has the right to hire that applicant at its sole discretion without the sending recruiter, person or organization receiving any fee. Recruitment companies who are Q-Med’s preferred partners send CV:s according to agreed routines and data privacy rules.
We wish to inform applicants that Q-Med can conduct pre-employment security checks for specific positions or activities. This security screening is performed by an external supplier after approval from applicants.
Publiceringsdatum2013-02-01Arbetstider och omfattningTillsvidare
ErsättningEnligt avtal
Så ansöker duSista dag att ansöka är 2013-02-18
Ansökan kan tyvärr inte göras via e-post.
Klicka på denna länk för att göra din ansökanKontaktFöretagQ-Med Q-Med
AdressQ-Med Q-Med
Seminariegatan 21
75228 Uppsala
Jobbnummer 1455509
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