Pharmacovigilance

Efficient PV systems for the Nordics

We help your company create key reference documents (SOPs and PSMF) for your personnel, on all aspects of day-to-day drug safety operations.

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Essentials of a pharmacovigilance system

Setting up a pharmacovigilance system is a critical step requiring a great deal of expertise in risk management planning, data collection, analysis, and writing/reporting standards. This includes SOP writing and creation of PSMF.

 

Why use our support with PV system maintenance?

Arex Advisor experts will:

  • Create a pharmacovigilance system, including writing and reviewing of relevant SOPs describing the PV process
  • Create and maintain a PSMF file compliant with the applicable regulatory guidelines
 
More pharmacovigilance services

Adverse event management and case reporting
Scientific literature screening
Local PV function, including medical information
PV training services

Your contact person

Lovisa Rosenquist

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.