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Drug Safety Medical Writer (m/...

 
 
 

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:

 

Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Straße 235, 1100 Vienna, Manfred Weinzerl, MSc

T: +43 (1) 610 32 – 4515, www.octapharma.com                  

apply here

 

Key facts about Octapharma Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell-lines. Octapharma employs approximately 7.200 people worldwide to support the treatment of patients in over 100 countries with products across the following therapeutic areas: Haematology (coagulation disorders), Immunotherapy (immune disorders), Ciritical Care. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico. For more information visit www.octapharma.com

 

Key facts about Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell-lines. Octapharma employs approximately 6,000 people worldwide to support the treatment of patients in over 100 countries with products across the following therapeutic areas: Haematology (coagulation disorders), Immunotherapy (immune disorders), Ciritical Care. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico. For more information visit www.octapharma.com