Senior PV specialist Growing Biotech

Copenhagen

Are you looking for your next step in Pharmacovigilance? Would you like to work with a dynamic Biotech company there is take off? Ohh my, then I have something for you!

I am looking for an Experienced Pharmacovigilance specialist to working with a growing portfolio of drugs and whit the company being the small/mid-sized there will be plenty of opportunities to grow and expand with the company into a more specialised role or even Line management, so if you want to refine your skills and get ready for that next jump in your career, then this is your chance.

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 C.hogh@nonstop-recruitment.com 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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