Closing Date: 12 Nov 16
Salary (£): Competitive
COVANCE is seeking a Project Manager with experience in Drug Safety to join our expanding Safety team in our Maidenhead office (UK), Italy, Spain and Bulgaria (both permanent and contractors) http://jobsearch.covance.com/jobs/1290846-Project-Manager-Drug-Safety.aspx
PROJECT MANAGER-DRUG SAFETY
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities.
We are currently seeking a proactive, driven Project Manager with Experience in Drug Safety to join our expanding Safety team in our Maidenhead office (UK), Italy, Spain and Bulgaria - both permament and contractors.
The successful candidate will provide oversight of the receipt and processing of all adverse event reports, either spontaneously from any source or from a clinical trial for assigned projects. The individual in this role will have responsibilities including but not limited to the following:
About the Job
- 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.
- 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.
- Complete triage, distribution checklist and quality review of all ESRs 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.
- Monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget.
- 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.
- Provide PV&DSS project training for assigned projects for PV&DSS, Clinical Operations/Project Management, Client and Investigators as required.
- Manage the set-up of, and the provision of data to Safety Committees / Drug Safety Monitoring Boards.
- Work with Data Management or client on reconciliation of safety databases, if appropriate.
- Maintains 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.
- Responsible 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.
- Build and maintain good drug safety relationships across functional units.
- Financial authority as it relates to projects.
- Significant relevant drug safety Experience (*Safety Experience includes actual Experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and Experience with regulatory submissions).
- Compliance with client and global regulatory requirements
- Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines Good knowledge of ICH GCP guidelines.
- You will possess good verbal, written and presentation skills.
- The ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
- Have a high degree of accuracy with attention to details.
- Possess the ability to present and share useful business information across departments and functions.
- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
- Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
- Good knowledge and understanding of industry and R&D processes and objectives
- Ability to work independently with minimal supervision
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
- Knowledge of Periodic Safety Update Report (PSUR) desirable
- Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
Covance's ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
There is no better time to join us!
Education/Qualifications See above
Experience See above
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. Your confidentiality and privacy are important to us.
Maidenhead, United Kingdom
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