[Hiring] Manager, Safety & PV (Data Management oversight) @Syneos Health

Role Description

Manager, Safety & PV (Data Management oversight)

• Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counseling.
• Advises staff on administrative policies and procedures, technical problems, and prioritization.
• Assigns project work and reviews workload for all direct reports.
• Provides oversight and guidance on organizational goals and company objectives.
• Ensures that data is accurate, complete, conform, consistent and current.
• Maximizes the value of the data within an organization.
• Ensures that the data is available to the relevant stakeholders.
• Complex data services (mapping/enrichment/cleansings) analysis in bulk; Quality assurance; Service coordination (with IT teams, with data governance, across data management workstreams); Performance management (Reporting, Managing KPI compliance, Invoicing).
• Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan.
• Discusses below-target project goals with senior safety management.
• Manages projects where Safety and Pharmacovigilance are the primary services.
• Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed.
• Works with Finance to ensure appropriate customer invoicing, where required.
• Approves project time cards and invoicing.
• Provides sponsors with scheduled project updates and reports.
• Coordinates with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues.
• Participates in the management of the Safety and Pharmacovigilance department with the following actions:
• Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs).
• Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan.
• Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes.
• Participates in process development and improvement of departmental functions.
• Represents Safety and Pharmacovigilance or ensures Safety representation at project team meetings and client meetings.
• Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure information is consistent with the Serious Adverse Event form.
• Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug development process.
• Responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups.
• Mentors Safety team members.
• Manages resourcing's needs/issues and escalates to senior management as necessary.
• Participates in audits/inspections and ensures inspection readiness.
• Participates in quality investigations and implementation of corrective and preventive actions.
• Performs other work related duties as assigned.
• Minimal travel may be required.

Qualifications

• Equivalent experience, skills, and/or education will also be considered.

Requirements

• Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
• The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
• The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
• Nothing contained herein should be construed to create an employment contract.

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.