Associate Director, Drug Safety

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Job title: Associate Director, Drug Safety

Company: Labcorp

Job description: Responsible for managing the Drug Safety Services regional operations group (Europe, Asia-Pacific or The Americas).

Responsible for ensuring all projects are allocated and set up in accordance with capabilities and current/expected workload, that assigned staff are adequately trained and developed, and that all projects remain on time and within budget.

Responsible for ensuring the processing of expeditable adverse events meet the required standard, and submitting these events to the clients and 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 a stand-alone business.

It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner

¨May manage from 1-5 direct reports and 6-10 indirect subordinates.

  • Managerial and Leadership duties and responsibilities:
  • Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues
  • May manage individuals across multiple teams and will take on responsibility for cross department projects
  • Participate in Labcorp project teams and provide training about adverse event reporting to non-safety personnel
  • Train new employees overall in pharmacovigilance and regulatory reporting
  • Assist with the recruitment of new staff to Drug Safety Services
  • Ensure the set up and maintenance of project files and core process files.
  • Contribute to the generation and review of Time and Cost Estimates for Drug Safety Services business.
  • Review safety costs for allocated projects, identify out-of-scope/unauthorized activities and work with the appropriate business units to process change orders, expeditiously.
  • Provide appropriate and relevant PV&DSS input into project management, including risk analysis, control metrics and contingency planning.
  • Liaise with medical, clinical, data management and regulatory personnel regarding safety issues, as appropriate.
  • Support Business Development (BD) activities including client presentations and accurate input for costings and proposals.
  • Work with BD Costings and Proposals to provide time and cost estimates for new upcoming projects and staffing needs
  • Provide safety representation on project proposal teams and participate in business development meetings with potential new clients to ascertain their overall safety capabilities and needs
  • Provide input on all safety-related presentations for global use
  • Provide and discuss operational metrics on an ongoing basis to assist with continuous validation of the drug safety costing algorithms
  • Ensure efficient, effective and economic operation of PV&DSS including management of quality, regulatory compliance, and adherence to project budgets.
  • Participate in discussions of strategy, planning and review of global/local practices
  • Provide safety data to support regulatory submission personnel for annual reports
  • Review and provide input on global Standard Operating Procedures (SOPs) and Work Instructions (WIs) involving safety, plans and documentation to ensure all PV&DSS units are aware of and work in accordance with ICH, FDA and Asia-Pacific regulatory requirements
  • Interface with Information Technology (IT) regarding validation and utilization of safety databases
  • Ensure timely and appropriate reporting of expeditable adverse events to clients, regulatory authorities, ethics committees and investigators, as required
  • At times, execute routine quality review of AE reports and aggregate reports for other members of PV&DSS ensuring that case processing and data quality meet global regulatory compliance needs, including audit support.
  • Discuss project status at regular meetings with operations staff and ensure tracking sheets are updated appropriately
  • Ensure the effective collection of departmental metrics
  • Assess current and potential issues with quality and timeliness of work
  • Discuss issues with and interpretation of regulatory reporting requirements with the Global Medical and Regulatory consultant
  • Discuss general medical safety issues
  • Maintain complete understanding of Labcorp’s safety database conventions and system functionality.
  • Provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).
  • Match available adequately trained staff resources to business needs.
  • Ensure competency and skills are appropriate to projects, and provide identified training needs
  • Ensure departmental working practices are in accordance with training, and identify any areas requiring clarification or additional training
  • At project win stage, ensure that allocation of resources is predicted and managed for all projects
  • Apprise the Executive Director, PV&DSS of resource requirements in advance of new projects or when additional coverage may be required in times of excess volume of work
  • Provide support to others members of PV&DSS Management Team for periods of absence, vacation and busy periods
  • Review metrics to evaluate current safety workload to forecast impact on future staffing needs
  • Participate in interviews, selection and training of new PV&DSS staff members
  • Generate and maintain a productive working environment for all teams in region.
  • Provide effective direct management of PV&DSS operations staff
  • Conduct regular staff meetings to provide a forum to facilitate good communication
  • Review and assess Performance Management and Development (Objectives and Development) Plan with direct reports as per CDS schedule
  • Build and maintain good drug safety relationships across functional units.
  • Demonstrate Leadership Competencies on a consistent basis.
  • Demonstrate company Values on a consistent basis.
  • Review and approve Adverse Event Reporting Plans (AERPs), Reconciliation Plans, Randomization and Unblinding Plans, Endpoint Plans, Drug Safety Monitoring Board (DSMB) Charters, Post-marketing Surveillance Plans and any other client-specific safety plans ensuring optimal efficiency.
  • Provide support and personnel for, and participate in, pre-contract audits, client audits, project team meetings and investigator meetings.
  • Act as the primary safety contact for clients who prefer to have a more senior level individual as their primary contact.
  • Attend client meetings/teleconferences, as necessary.
  • Ensure comparison of metrics collected vs. those costed for, and time billed to, identify out-of-scope projects.
  • Discuss corrective actions for out-of-scope projects to enable the preparation of change orders.
  • Any other duties as assigned by management.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant’s race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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Expected salary:

Location: Bangalore, Karnataka

Job date: Wed, 19 Oct 2022 22:40:36 GMT

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