Project Manager, Drug Safety - Medical Devices

Edinburgh, , United Kingdom
Closing date
3 Oct 2020

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Clinical Research, Drug Safety, Pharmacovigilance
Full Time
Contract Type
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Job Overview:
Covance are looking to hire an experienced Drug Safety Project Manager - Medical Devices, the position can be home based in Europe. We are looking for candidates who have Device experience and specifically Clinical Trial Device experience and not just Post Marketing

Essential Job Duties:
  • Provide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects.
  • Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with International reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
  • Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
  • Work closely with the clinical operations and project management groups to ensure all PV&DSS activities are performed according to the regulatory and contractual requirements.
  • Provide oversight of the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.

Education/Qualifications: Minimum Required:

Level of education required (or experience level which may be substituted for level of education).

Professional designations/certifications/licenses required
  • Non-degree + 6-7 yrs safety experience*
  • Associate degree + 5-6 yrs safety experience*
  • Associate degree RN + 5-6 yrs safety experience*
  • BS/BA + 4-5 yrs safety experience*
  • MS/MA + 3-4 yrs relevant experience** (2-3 yrs safety experience)
  • PharmD + 2-3 yrs relevant experience** (1-2 yrs safety experience)

For PharmD, a one year residency of fellowship can be considered relevant experience.

Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.

*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.

**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.

EudraVigilance Certification preferred
Experience: Minimum Required: We are looking for candidates who have Device experience and specifically Clinical Trial Device experience and not just Post Marketing. We are looking for candidates who have experience in Drug Safety Project Management. This is a a challenging role where every day is different. The position would suit a self starter.
  • Compliance with client and global regulatory requirements
  • Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines.
  • Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
  • Good knowledge of ICH guidelines.
  • Good knowledge of medical and drug terminology
  • Work collaboratively with PV&DSS Management's team
  • Good verbal, written and presentation skills.
  • Fluent in English
  • Leadership capabilities
  • Knowledge of aggregate reporting
  • Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
  • Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
  • Financially intuitive

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Join our growing team and discover your extraordinary potential

We are recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, our comprehensive service portfolio provides the opportunity to explore diverse projects and unique career paths across the drug development spectrum.

Please visit our Careers Hub

Learn more about our work to improve health and improve lives:

Contact Us
  • Maidenhead Office Park
  • Westacott Way
  • Maidenhead
  • SL6 3QH
  • United Kingdom
  • Mini-site: Covance
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