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Drug Safety Medical Writer (m/f)

As an international family business of manufacturing Human proteins we are proud of this: our products save lives. We have strong European roots and are growing continuously. Therefore and as a maternity leave replacement, we are looking for a
 
Drug Safety Medical Writer (m/f)
Limited to 03.2020

Your tasks are diverse – from Preparation of postmarketing reports over the collaboration with other internal functions to the analysis of risks of products. This includes:

  • Preparation of postmarketing aggregate safety reports for regulatory submission, such as PBRERs/PSURs, RMPs and associated documents
  • Review and assessment of related safety data
  • Compilation/review of product core safety information
  • Collaboration with other functions concerning safety issues relative to safety writing activities such as pharmacovigilance personnel, toxicology, R&D and clinical research departments, products quality, regulatory affairs and marketing
  • Ensure all periodic safety regulatory documents are processed and submitted according to regulatory requirements worldwide
  • Assist with the creation and maintenance of relevant standard operating procedures (SOPs)
  • Participate in ongoing safety data review, analysis and assessment of products’ risks and benefits
  • Maintain awareness of changes to/new regulations affecting pharmacovigilance activities

What we expect?

  • Completed academic degree, ideally in a medical  or healthcare discipline
  • Experience in pharmacovigilance, medical writing and preparation of safety documents would be an advantage
  • Very good verbal and written English skills as well as communication and presentation skills
  • Team player with a strong focus on timelines
  • Good level of computer literacy, in particular in the use of databases, MS Word and MS Excel
  • High degree of accuracy with attention to detail
  • Excellent critical, analytical and problem solving skills

What we offer?

  • Versatile tasks in an international environment, flexibility and self-responsibility
  • Familiar surroundings of a family business with benefits such as Do & Co company restaurant and exceptional employee events
  • Reliable employer with generous social benefits and marketable payment. The basis for this position: Collective agreement for employees of the chemical industry VG III

Do you want to become a member of the Octafamily? We look forward to receiving your application:

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Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Vienna, Manfred Weinzerl, MSc
T: +43 (1) 610 32 – 4515, www.octapharma.com