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