Covance Manager, Drug Safety in NC, United States

Job Overview

Manger, Drug Safety Job Summary:

  • Line Manage DDSS&A staff including performance reviews, human resource issues, inclusive of the Drug Safety Project Managers (DSPM) as well as Senior Drug Safety Associates SR. DSA across the DDSSA group.

  • Manage ‘Client’ or ‘Project’ specific Drug Safety Solutions and Adjudication (DDSS&A) operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports) for specified projects.

  • Manage and provide oversight to staffers who process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.

  • Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.

Essential Job Duties:

  • Provide leadership and management of assigned global projects and/or programs ensuring that communications and processes are harmonized.

  • Plays integral role in the preparation of proposals and assumption documents.

  • Responsible for monitoring overall project health/performance and provide status/metric reports to senior management as well as key stakeholders (using project management tools within her/his team).

  • Attend the monthly Drug Device Safety solutions Dashboard review

  • Assists the Drug Safety Project Manager (DSPM) with project budget planning, forecasting and financial management

  • Monitors project deliverables regarding contract assumptions by following up with DSPMs; identifies out of scope work or potential to run over budget; and provides necessary data to support Change Notification Forms and/or Change Orders.

  • Resolves conflicts as needed and manages relationship with the clients and key vendors/stakeholders by providing expert safety knowledge, when necessary.

  • Proactively identifies process related obstacles and supports development of contingencies based on the risk evaluation.

  • Monitors and provides support on different project related safety issues, steers and facilitates global meetings, and follows up on action items/initiatives to ensure safety actions are addressed.

  • Responsible for the review of Safety Management Plan (SMP), protocols and any other study related documents.

  • Supports the DSPMs and the safety teams on audits (internal and external) and inspections.

  • Supports management in assigning resources to projects.

  • Line manages the team including performance reviews.

  • Assist with the recruitment and training of new staff.

  • Shares safety knowledge and expertise to project team via training and mentoring.

  • Manage direct reports to ensure staff training records are up to date.

  • Develops positive team environment and good working relationships across functional units.

  • Provides ongoing performance feedback to project team members.

  • Implement and monitor progress against project plans and revise as necessary.

  • Prepare and actively participate in internal Project Review Meetings as needed.

  • Use experience from past projects and lessons learned to adapt and implement quality improvements across projects currently being managed.

  • Perform any other duties as assigned by management.

  • Provide Support of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.

  • 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.

  • 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.

  • Assist in coaching new team members, training them as needed, by helping them to make decisions, solve problems, and manage budget/goals.

  • 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

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 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)For Pharma D, 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 AS/SAE reports, generating narratives, queries, working within safety database, and experiences 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:

  • 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 (DDSS&A) Management’s team

  • Good Verbal, written and presentation skills

  • Good communication

  • Client facing experience advantageous

  • Leadership capabilities

  • Anticipate/identify problems and takes appropriate action to correct

  • Knowledge of Medical Device Reporting desirable

  • 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 2018-18348

Job Category Other

Position Type Full-Time

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