Medical Safety Director (Sweden)

This search procedure has been closed (18-05-2016).
Field
Healthcare
Salary
Salary undisclosed
Location
Amsterdam
Employment
Permanent
Headhunter
HAYS

The organisation

Our client is a global company which provides medical solutions which meet the dermatological needs of people. 

The position

In this role, you are responsible for the Global responsibility for the safety and risk mitigation for the company's portfolio of medical devices, post market and in clinical trials, responsible for medical device vigilance safety and risk mitigation, ensure preparation and reporting of adverse events and related responses to regulatory bodies, oversight of aggregated safety reports, oversight to ensure that risk management analysis and plans are updated annually, oversight of safety signal detection procedures and monitoring of the safety profile of our devices, ensure safety assessments documents preparation for submission to regulatory bodies to maintain product renewals, escalate the appropriate safety issues to the GBU and Corporate Medical Management, lead and ensure resources for conducting product safety investigations and to advise VP Corporate Medical Affairs, VP Medical Affairs A&C, and site senior management. 

Furthermore you are responsible for risk mitigation, potential recall and withdrawal, oversight of medical device quality and vigilance system. This consists oversight and promote continuous improvement of the quality system and policies for the vigilance of medical devices, review of all relevant SOP’s and policies prior to approval in order to ensure consistency and compliance across the organization, ensure that vigilance personnel is adequately qualified and trained, including in ISO 13485 and relevant applicable regulations etc. 

Also you are responsible for the supervision and management of medical device safety department, which consists: manage directly a Head of Safety and Risk Management and indirectly reporting to him , vigilance associates, vigilance manager, vigilance scientist and ensure adequate resources for management review, product risk management, annual product review, post market safety surveillance yearly or more often as required, as well as all aspects to ensure successful outcomes at audits. At last you need to be able to oversee medical evaluation of adverse events for marketed portfolio of medical devices, post-market and in clinical studies, provide medical input to internal and external enquiries concerning adverse events and potential medical safety issues, medical lead for conducting product investigation and medical assessment of newly identified and potential risks and have the recommendations for risk management plans. 

Candidate profile

The perfect candidate has Post-graduate clinical experience preferably at a university or teaching hospital, a minimum of 5 years’ experience from the pharmaceutical industry within device vigilance or pharmacovigilance, a high level of experience in people management skills and experience in a team management, achievements in cross-functional projects. 

Furthermore you are excellent in analyzing scientific data and drawing the relevant conclusions, experience as investigator in clinical studies on drugs or medical devices is a merit, excellent skills in medical writing; and in communication and presentation to a scientific audience, have good knowledge in MS Office applications and are fluent in spoken and written English. 

Terms & conditions

Good annual payment, dynamic company and possibilities to expand the team. 

Interested?

You can apply to this position by using the link below.

This search procedure has been closed (18-05-2016).

About this headhunter - HAYS

Bij Hays geloven we dat de juiste persoon een organisatie kan veranderen. En de juiste baan geeft veel energie en zorgt ervoor dat je elke dag met voldoening naar huis gaat.

Als één van de grootste recruitment specialisten wereldwijd plaatsen wij gekwalificeerde kandidaten in vaste, tijdelijke, interim en contracting jobs. Met zo'n 12.100 mensen wereldwijd, helpen wij mensen te slagen en organisaties te groeien, we creëren kansen en proberen zo levens vooruit te brengen.

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HAYS has been active on Lintberg since 2008.