We have an exciting vacancy at Covance for a Drug Safety Project Manager. This can be based anywhere in the EU - but preferred locations would be Bulgaria (Sofia) or Poland or UK.
It is a permanent position.
The role will involve:-
Leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects.
Monitoring and managing 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..
Working closely with the clinical operations and project management groups to ensure all PV&DSS activities are performed according to the regulatory and contractual requirements.
Providing 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.
Providing oversight of the management and processing of expedited safety reports (ESRs) for assigned projects
Executing quality review of all AE reports and safety reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs
We are looking for someone with strong Safety experience, and candidates with client facing experience, financial management experience e.g. budget reviews, project lead experience and experience with Eudravigilance are preferred.
The DSPMs at Covance are responsible for the Safety project management of studies with Safety services in scope; management of the start-up activities e.g. Safety management plan writing, client Kick Off Meetings, oversight and training of assigned project resource, Argus database setup, EudraVigilance management, plus the oversight and management of study financials, preparation of periodic Safety reports (including the Developmental Safety Update Report), and oversight of all study deliverables e.g. SAE handling/Safety reporting.
• 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