Senior PV specialist, be a key player at Danish Biotech

Apr 16, 2018
May 16, 2018
CH. 184923.2
Casper Hogh
Jobseeker Type
Organization Type
Contract Type
Full Time


Are you looking to work with risk management, DSUR and Suvalice, Yep the whole package, step into a key position in the Pharmacovigilance department at a rapidly growing Biotech? Then I got just the thing that you are looking for!

If you are passionate about making a clear difference for your patience and work for a company where you have direct Influenced the directions that the company is going, then this is not a chance to join a well established, but growing Biotech, as they take on Industry changing projects.

The company is not the biggest in the industry, that means that as they grow you will be able to grow with the company in any direction that you wish, so if you wanna go full blown Specialist or maybe your heart is that of a mangers, then you will have ample opportunity to shape your further the way you want it.

You will report to the Head of Pharmacovigilance.

Key responsibilities:

* Ongoing safety surveillance
* Signal management
* Aggregated safety reporting

The Job Requirements
* perform safety surveillance activities for the clinical projects assigned
Perform signal detection activities, to support the evaluation and decisions of Safety Committee.
* Preparation of periodic safety reports (DSUR, periodic SUSAR reports)
* Preparation of Risk Management Plan (RMP) and Risk Evaluation and Minimization Strategies (REMS) documents
* Support the design and execution of the assigned clinical programs from a clinical safety perspective.
* Provide drug safety expertise to project teams, including all relevant documents prepared for regulatory submissions for the assigned clinical programs

Education And Experience

* MD degree or other relevant life sciences degree; Pharmaceutical Medicine or Pharmacovigilance degree will be an advantage
* 5+ years of hands-on work experience with the PV processes applied in safety surveillance (including safety analysis, signal management, DSUR/PSUR, RMP/REMS, internal safety committees, communication with regulatory authorities)
* understanding of the PV requirements for Eu and US

If you are interested, then get in touch with, Casper Skyum Hogh on +45 78 79 47 40 or email your CV in M.S Word format to to find out more about this position, or any other.

I am a specialised recruiter within Clinical research and Pharmacovigilance in the Pharma, Biotech and Medical Device industry. I, therefore, have access to an extensive network within these industries, which aren't available otherwise. If the above opportunity doesn't have your interest, but you would like to hear more about potential opportunities, then you are welcome to contact me for a noncommittal, confidential chat.

If you know someone in your network who may be interested in the above, then you are more than welcome to pass on my details to them, so that I can be of assistance to them.

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