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Drug Safety Medical Writer – Maternity Leave Replacement (m/f/d)

Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are looking for a maternity leave replacement (until March 2020) as

Drug Safety Medical Writer – Maternity Leave Replacement (m/f/d)

Research & Development

Your new challenges which will inspire you:

  • 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

Your profile that will convince us:

  • 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

Our attractive benefits for you:

  • Wide range of tasks in an international setting, flexibility and personal responsibility
  • Reliable employer with generous employee benefits and a salary customary in the market.
  • Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant,
  • extraordinary staff events and many more:

Octapharma Pharmazeutika Produktionsges.m.b.H.

Additional information:

The minimum gross wage according to the collective agreement (chemical industry) for your new job is EUR 2.602,36. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay wages higher than collectively agreed.

We are looking forward to new, committed employees who join forces with us to promote our strong growth in order to keep enabling our patients to live a better life - because it is in our blood! Is it in your blood too? We are looking forward to receiving your application via our online career portal.

Stellenangebot, Job, Drug Safety Medical Writer, Octapharma Pharmazeutika Produktionsges.m.b.H.

Your contact:

Mag. (FH) Charlotte Ponzer Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien,
T: +43 (1) 610 32 – 1301

About Octapharma

As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Our company values are Ownership, Integrity, Leadership, Sustainability and Entrepreneurship.In 2018, the Group achieved €1.8 billion in revenue, an operating income of €346 million and invested €204 million to ensure future prosperity. Octapharma employs more than 8,300 people worldwide, 1,200 of them in Vienna, to support the treatment of patients in 115 countries with products across three therapeutic areas:

  • Haematology (coagulation disorders),
  • Immunotherapy (immune disorders) and
  • Critical Care

Octapharma owns six state-of-the-art Production facilities in Austria, France, Germany, Mexico and Sweden.