Doctor needed for Copenhagen based consulting company

Steen Ottosen ApS is niche consulting company providing Drug Safety and Pharmacovigilance services to a number of successful pharmaceutical companies especially on the United States West Coast needing top level medical safety expertise.

We are experiencing a rapid expansion of the activities and are therefore looking for local experts to join the company primarily on a consulting basis since we are establishing a presence in Odense.

Steen Ottosen ApS is mostly a virtual company with highly specialized consultants around the world so most of the work is done from home. We do meet to coordinate training and work activities dependent on the workload.

Currently we are looking for staff with clinical expertise as well as clinical trial experience with interest drug safety and pharmacovigilance. The clinical expertise can be from any area, but we do especially need expertise in oncology and cardiology at the moment.

We do operate as a team, but the job also requires the consultant to operate independent with responsibility for quality and deadlines for one or more clients. Training and support will of cause be provided, but you have to expect that things move fast, and you will have to learn new tasks quickly.

The typical work includes a wide variety of tasks dependent on experience level and training. Here are some examples:

  • Managing own projects and some general projects
  • Track time for invoicing in online tool
  • Medical assessment of serious adverse events
  • Medical monitoring of clinical trials and quality and consistency review of trial data
  • Medical coding review
  • Development of standard operating procedures
  • Audits and Inspection Support
  • Safety Signal Detection and Analysis
  • Risk Management
  • Safety Management Team meeting support and analysis
  • Support for Data safety Management Boards
  • Writing of safety related study reports, periodic reports like PSURs and DSURs
  • Development of Risk Management Plans
  • Interactions with regulatory authorities
  • Qualified Person for Pharmacovigilance Service
  • PV Master File services

 It is an independent consulting job which is quite flexible where you plan your own work while adhering to agreed time lines. You can work few or many hours dependent on your availability and the clients you support. Most of the work is done at the time of the day you choose but any meetings with clients are usually from late afternoon and during the evening when needed.

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Oprettet d: 03/04/2019
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