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Job Details

Drug Safety Coordinator/Safety Specialist

Company: Medpace
Location:
Reference: DESC1118
Closing Date: 23 Dec 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Medpace is looking for a Drug Safety Coordinator/Safety Specialist to join our team in Munich, Germany

Requirements:

Drug Safety Coordinator/Safety Specialist

Location: Munich, Germany

Overview:

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,700 people across 36 countries.

Job Summary

Our European activities are growing rapidly, and we are currently seeking a full-time, office-based Drug Safety Associate to join our Germany team and to be based at our growing Munich office. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success.

Ours is a culture of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our partners. At Medpace our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons talented individuals join the Medpace team.

If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

  • To work closely with the Clinical Safety Manager to ensure each project deliverables are met;
  • Collect, process and track Serious Adverse Event (SAE) reports;
  • Generate study report narratives and CIOMS-I forms;
  • Daily interaction with investigative sites across Europe and Internationally;
  • Coordinate and prioritise daily project specific safety surveillance duties;
  • Oversight of submission of safety reports in the appropriate format to Competent Authorities/Ethics Committees in compliance with regulatory timelines;
  • Perform data entry of events into the EudraVigilance portal;
  • Regular interaction with other internal departments globally and locally, such as, Clinical Operations, Data Management and Regulatory Submissions;
  • Draft study specific safety documents as required; and
  • Training and mentoring of other team members.

Qualifications

  • Min. of bachelor’s degree (or equivalent) in a health or life science related field;
  • Previous experience of working within Pharmacovigilance;
  • Excellent time management skills with an ability to work to tight timelines;
  • An ability to interact well within a team environment, but also work independently and manage own workload;
  • Comprehensive understanding of Microsoft office suite; and
  • Attention to detail.

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities. 

Awards

  • Medpace Named a Top Cincinnati Workplace for 2015, 2016, 2017 and 2018 by the Cincinnati Enquirer
  • Winner of the ACRP-Avoca CRO Quality Award in 2018
  • Recognized with six CRO Leadership Awards from Life Science Leader magazine
  • Eagle Award winner - which recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through strong site partnerships

What to Expect Next

We look forward to receiving your application.  A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

Apply for this job: Drug Safety Coordinator/Safety Specialist

Contact Information:

Address:  Medpace Germany GmbH
Theresienhoehe 30 80339 München Germany
80339
Germany
Tel:  +49 (0) 89 89 55 718 0
Website:  Visit Our Web Site

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