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Job Details

ASSOCIATE DIRECTOR OF DRUG SAFETY CENTER - Germany

Company: PRA Health Sciences
Location: Mannheim, Germany
Reference: AB-2017-43597
Closing Date: 03 Dec 17
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary and Benefits

Job Summary:

An outstanding opportunity to join one of the world’s leading contract research organisations and be part of a dynamic and growing international company. Join PRA Health Sciences as a Associate Director Drug Safety Center and help realize your career potential.

Requirements:

ASSOCIATE DIRECTOR OF DRUG SAFETY CENTER

Location: Mannheim, Germany.

As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 70+ such drugs.

At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 13,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.  

For more information please see our website: www.prahs.com

Job overview:

We are currently recruiting for an Associate Director Drug Safety Center to lead our Safety Data Coordinator team in Mannheim, Germany.

The Associate Director is involved in directing the Drug Safety Center to provide services for SAE/ADR management, periodic safety reports, investigation of safety issues, safety consulting on processes, tools, and regulatory requirements related managing the safety of drugs, vaccines, and devices throughout the life-cycle of a product.

The role will include: 

  • Leading a team of manager level staff Recruiting new employees
  • Ensuring staff development and performance feedback are provided through activities such as career development and mentorship
  • Monitoring projects to assure profitability and project objectives are being met
  • Building and aligning technical teams to perform critical operating tasks
  • Identifying and implementing process improvements
  • Representing the Business Unit as part of global initiatives

Your profile: 

  • Substantial pharmaceutical or contract research organization experience including project leadership
  • Minimum of 7 years of experience in pharmacovigilance or related services and at least 4 years in a managerial role
  • Experience in coding in the clinical database (MedDRA and WHO Drug), SAE reconciliation, and adjudication support
  • Knowledge of regulatory submissions requirements for human drugs, biologics, and/or devices required
  • Knowledge of relevant ICH report writing guidelines, and regulatory submission requirements for human drugs in North America and Europe
  • General knowledge in data management
  • Experience using computerized systems (PC-Windows and Word, Excel, PowerPoint)
  • Fluency in English and German
  • An advanced degree (M.S. or Ph.D.) from an accredited institution in medicine, pharmacy or other life-sciences or a health-related field or equivalent degree

Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.

The role is based in Mannheim, Germany.

If you have any questions please email recruiteruk@prahs.com or call our recruitment department at +44 (0) 1189 213652 

PRA Health Sciences is an Equal Opportunity Employer.  We welcome and encourage diversity in the workplace.

Apply for this job: ASSOCIATE DIRECTOR OF DRUG SAFETY CENTER - Germany

Contact Information:

Address:  Head Office
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
England
Tel:  +44 (118) 918 1000
Fax:  +44 (118) 918 1001
Website:  Visit Our Web Site

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