OFERTA DE TRABAJO Project Manager Drug Safety, Europe JOB OFFER

Job Overview:Covance have an opportunity for a Project Manager - Drug Safety to join the team. This is a full time, permanent position - home or office based.

Responsibilites:

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.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. This includes, but is not limited to:entry of safety data onto adverse event database(s) and tracking systemsreview of adverse events for completeness, accuracy and appropriateness for expedited reportingwrite patient narrativescode adverse events accurately using MedDRAdetermine expectedness/listedness against appropriate labelidentifies clinically significant information missing from initial reports and ensures its collectionensure case receives appropriate medical reviewprepare follow-up correspondence consulting with the medical staff accordingly ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelinesreporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelinesprovide independent QC of AE reports for other members of the groupProvide oversight of the management and processing of expedited safety reports (ESRs) for assigned projects. Execute and/or ensure routine quality review of adverse event reports and aggregate reports ensuring that case processing and data quality meet global regulatory compliance standards for assigned projects.Provide oversight and management of EudraVigilance activities for assigned projects.Preparation of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.Provide oversight and/or preparation of timely pharmacovigilance reports for products and safety issues, including but not limited to Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting.Monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget.Contribute to the generation and review of Time and Cost Estimates for PV&DSS business.Generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.Attend client meetings and liaise with clients where appropriate.Manage the review of cumulative safety data for submission to DSMBs, regulatory authorities or clients.Manage the set-up of, and the provision of data to Safety Committees / Drug Safety Monitoring Boards.Contributes to the development and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms.Prepare and deliver safety presentations:Serious Adverse Event reporting at investigator meetings.Client capabilities meetings, as appropriateDepartment Overview to internal clientsMaintains a comprehensive understanding of PV&DSS SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.Provide support and training in all aspects of case-handling, adverse event reporting and other tasks for team members of assigned projects.Acts as a mentor to less experienced colleaguesResponsible for cascading relevant information from internal and external meetings to PV&DSS management and appropriate colleagues.May supervise workloads and individual performance of more junior team members

Education/Qualifications: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:

Experience in PV and managing PV projectsUnderstanding of budget and scope managementCompliance with client and global regulatory requirementsGood knowledge of the relevant worldwide pharmacovigilance regulations and guidelines, GCPrelated to clinical safety documentation,ICH guidelines,medical and drug terminology.Leadership capabilitiesAnticipate/identify problems and takes appropriate action to correct.Knowledge of aggregate reportingAwareness of the regulatory environment regarding Risk Management and Pharmacovigilance.

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