Covance Proj Mgr Drug Safety - Medical Device in Sofia, Bulgaria
Covance is looking to recruit Drug Safety Project Manager - Medical Devices.
Provide leadership and management of global or regional projects/programs ensuring that communications and processes are harmonized for assigned projects. Depending on size and scope of project, this job duty may be performed in collaboration with a Principal Drug/Device Safety Project Manager and/or Manager of Drug/Device Safety Solutions and Adjudication (DDSS&A).
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.
Monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget and escalate to upper management as needed; and provide necessary data to support Change Notification Forms and/or Change Orders.
Track and monitor changes to the project scope, project schedule, and project costs using appropriate verification techniques.
Define and manage internal resources and third parties/vendors at a study level, proving feedback to upper management as needed.
Maintenance of adverse event reporting requirements in all countries. 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 (DDSS&A) activities are performed according to the regulatory and contractual requirements.
Provide oversight of the receipt and processing of all adverse event reports/ expedited safety reports coming from either spontaneously from any source or from a clinical trial for assigned projects. This might include, but is not limited to, executing routine quality review of AE reports ensuring that case processing and data quality meet global regulatory compliance needs.
Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.
Responsible for preparation and review of Safety Management Plans (SMPs), Reconciliation Plans and other specific plans, as applicable.
Contribute to the generation and review of Time and Cost Estimates for (DDSS&A) business.
Generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided. (Using project management tools within her/his team).
Prepare and deliver safety presentations at investigator meetings, client meetings, and internal meetings as appropriate.
Responsible for preparation and execution of risk management activities and project mitigation plans as needed, in collaboration with other team members.
Consistently contributes to solving technical and/or operational problems by proposing and executing innovative solutions which influence program/project direction.
Provide project specific to training Clinical Operations/Project Management, Client and Investigators as required. Provide support and training in study specific aspects of case-handling, adverse event reporting and other tasks for team members of assigned projects.
Prepare and participate in internal and external audits, and in regulatory inspections.
Manage the review of cumulative safety data for submission to Data Safety Monitoring Board (DSMB), regulatory authorities or clients.
Manage the set-up of, and the provision of data to Safety Committees/ DSMBs.
Work with Data Management or client on reconciliation of safety databases, if appropriate.
Contribute to the development and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms.
Maintain a comprehensive understanding of (DDSS&A) standard operating procedures (SOP), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
Contribute to the development of departmental Job Aids, WIs, and review of SOPs, as appropriate.
Ensure effective cross-functional global teamwork and maintain good team relationship across functional units.
Responsible for cascading relevant information from internal and external meetings to (DDSS&A) management and appropriate colleagues.
Act as mentor, supervise workloads and provide feedback to upper management about allocated project specific team member's performance.
Demonstrate role specific competencies on consistent basis.
Demonstrate company values on consistent basis.
Good understating of financial aspects of the project.
Any other duties as assigned by management.
Education / Qualifications
Non - degree + 6 to 7 years safety experience
Associate degree +5 to 6 years safety experience
Associate degree RN +5 to 6 years safety experience
BS/BA +4 to 5 years safety experience
MS/MA +3 to 4 years relevant experience ** (2-3 years safety experience)
Pharma D +2 to 3 years relevant experience ** (1-2 years safety experience)
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
Knowledge of Medical Device Reporting ESSENTIAL
Good knowledge of the relevant worldwide device safety regulations and guidelines.
Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
Good knowledge of ICH and ISO guidelines
Good knowledge of medical and device terminology
Work collaboratively with DDSSA Management's team
Good Verbal, written and presentation skills
Client facing experience advantageous
Anticipate/identify problems and takes appropriate action to correct
Knowledge of aggregate reporting
Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance
Good keyboard skills, preferable with knowledge of MS office and Windows would be beneficial
Job Number 2019-26956
Job Category Drug Safety/Pharmacovigilance
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.