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Drug Safety Manager

Employer
RBW Consulting
Location
Germany (DE)
Salary
€ Competitive salary based on experience including benefits
Start date
14 Sep 2021
Closing date
14 Oct 2021

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Discipline
Clinical Research, Drug Safety, Pharmacovigilance
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Clinical Safety Manager - Munich, Germany

Have you been working in Pharmacovigilance/ Drug Safety for a number of years and are looking for a new challenge within an established CRO? With your previous clinical trial PV experience within project management as well as line management experience, this could be the next right opportunity for you.

Our client is an award winning established full-service clinical contract research organization providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Their mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach.

This is an opportunity to join a small team working across a wide range of therapeutic areas.

Typical Responsibilities will include:

  • Manage Clinical Safety activities and multiple large programs.
  • Manage relationships with clients and internal stakeholders by providing expert safety knowledge;
  • Oversee clinical safety case management and aggregate reporting responsibilities to ensure client needs are fulfilled to a high quality;
  • Provide safety review of clinical study documents, including protocols, study reports; and marketing application components;
  • Create safety management plans dependent upon client;
  • Attend business development activities such as presentations to prospective Sponsors, participation in Sponsor audits, generation of scope of work and cost estimates;
  • Write departmental SOPs and Work Instructions.

Background / Qualifications:

You will ideally have a life science bachelor’s degree with Clinical trial PV experience including project management experience. Ideally you will have also gained previous experience in a line management capacity. Experience managing clinical safety activities for multiple programmes is an absolute must.

For further information on this role including salary and benefits, please get in touch directly on +44 (0)1293 364114

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