New opening for an Engaged Post Marketing Surveillance Specialist (PMS) at Ferrosan Medical Devices.
The company is located in Søborg within the greater Copenhagen area of Denmark. Ferrosan Medical Devices (FeMD) is a production company and an international organisation with a staff of 170 developing and producing hemostatic products employed in surgical procedures to control hemorrhage.
Products are registered as Medical Devices Class III and combination products.
The company is growing rapidly and product development is constant. The new PMS Specialist will primarily be gathering knowledge/data through search in literature, clinical evaluation etc. and together with QA, RA and Commercial Development, you will be able to get input in order to analyze and report the trending feedback from the market to Management Review.
The role as a PMS Specialist is a new established important role in FeMD to ensure the right focus on Post Marketing Activities for FeMD products to ensure compliance according to the new Medical Device Regulations (MDR). The post marketing data collected will provide the input to quarterly quality group meetings where management evaluates the products continued safety and effectiveness. In addition timely reporting of adverse events to authorities is within the responsibility of the PMS Specialist.
- An important, exciting and challenging position with a wide scope and many stakeholders.
- A strong culture in which cooperation, knowledge sharing and work satisfaction is important.
- A dynamic team consisting of experienced and dedicated people.
- A position in which you play an important role.
- Internal LEAN .
- The results of your performance will be registered throughout the organisation and will have an influence on the improvement of processes, etc. The flat organisational structure attracts people who thrive on the development of the business and enjoy being close to decisions.
You will report to Manager of Regulatory Affairs, and will be in a team of 3 colleagues.
The PMS specialist will be responsible for the execution of PMS activities and adverse event reporting at FeMD.
- Oversee and ensure that PMS activities always are in compliance according to Global applicable law and the internal standards of FeMD.
- Monitoring/ensuring those activities is constantly in compliance with applicable law.
- Ensuring the updating and effective functioning of quality system for PMS
- Ensuring effective functioning of processes for PMS and adverse event reporting.
- Maintaining positive communication both within the RA department and with other departments. Main stakeholders will be: RA, QA, Commercial Development and New Business Development.
- Responsible for the PMS plan/process and quarterly report (input to management review). In order to do that preparation of data analysis, reporting, trending and documentation review.
- Plan and call in for meetings with various stakeholders in order to inform, collect data for the report.
- Develop PMCF & PSUR reports to comply with the new MDR requirements for Medical Devices.
- Collect and review data, literature search, clinical evaluation and usefulness.
- Evaluate adverse events and collaborate as responsible person to authorities and information to Constituent Part Applicants according to applicable law.
- Close collaboration to the responsible for MDR and implementation of the new law within the role of PMS.
You have a background in pharmaceuticals, engineering or other relevant background from the natural sciences, and you have minimum 5 years’ experience from either the medico or Pharma industry. Background as PMS for Medical Devices, or experience from Pharmacovigilance or Medical Writing is preferred.
You are fluent in both written and oral Danish and English.
- You understand the regulatory landscape within the medical device and/or the pharmaceutical industry.
- You have business acumen and strategic insight.
- You have a positive and pragmatic attitude with focus on delivery on time.
- You are self-driven, positive and proactive, and you are able to take ownership and responsibility for your assignments.
- You create good working relationships with your colleague; you are a strong team player
- You have good communication skills .
- You have a positive approach and will take even a disappointing day with a smile.
Further information about this position may be obtained from Mrs. Hanne Beirholm, Beirholm Search, Tlph.: +45 29 44 00 80.
If you are interested and have the right qualifications, please forward your application including your CV as soon as possible. Interviews will be arranged ad hoc.