Manager, Safety & PV – Data Management Oversight

This is a fully remote position, open to applicants in Bulgaria.

📋 Description

• Oversee staff management tasks, including transfers, recruitment, resource allocation, terminations, training, professional growth, performance evaluations, timesheet approvals, and employee counseling.

• Offer guidance to staff on administrative policies, procedures, technical challenges, and prioritization of tasks.

• Delegate project assignments and assess workloads for direct reports.

• Provide direction and support concerning organizational objectives and company goals.

• Ensure the accuracy, completeness, compliance, consistency, timeliness, and availability of data to relevant stakeholders.

• Analyze complex bulk data services, including mapping, enrichment, and cleansing processes.

• Collaborate with IT teams, data governance, and data management workstreams to coordinate services.

• Monitor quality and efficiency in relation to contracted work scopes and Safety Management Plans.

• Manage projects where Safety and Pharmacovigilance are the core services.

• Evaluate study budgets and expenses while adhering to contractual and budgeting standards.

• Coordinate customer invoicing with the Finance department; authorize project time cards and invoicing processes.

• Provide sponsors with timely project updates and reports.

• Facilitate safety reporting reviews, submissions, document resolutions, and issue resolutions with internal departments.

• Engage in Safety and Pharmacovigilance departmental management and the development of Standard Operating Procedures (SOPs).

• Assess and enhance departmental processes and functions.

• Represent Safety and Pharmacovigilance in project team and client meetings.

• Review clinical safety components of study protocols and Case Report Forms (CRFs) for alignment with Serious Adverse Event documentation.

• Prepare and conduct training sessions for Safety team members and other departments; mentor team members.

• Manage resource requirements and escalate issues to senior management as needed.

• Participate in audits and inspections, conduct quality investigations, and implement corrective and preventive actions.

⛳️ Requirements

• Proven experience and expertise in overseeing safety and pharmacovigilance data management.

• Familiarity with complex data services, including mapping, enrichment, and cleansing techniques.

• Solid understanding of quality assurance and data governance principles.

• Experience in coordinating services across IT teams, data governance, and data management workstreams.

• Background in performance management, reporting, KPI compliance, and invoicing processes.

• Practical experience managing Safety and Pharmacovigilance projects.

• Knowledge of study budgets, expenses, and contractual considerations.

• Understanding of safety reporting processes and associated documentation.

• Familiarity with clinical safety segments of study protocols and Case Report Forms (CRFs).

• Compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans, and the drug development lifecycle.

• Capability to develop, review, and approve departmental SOPs.

• Ability to review and implement Safety Management Plans/Safety Reporting Plans effectively.

• Skill in identifying process improvements and suggesting enhancements.

• Competence in providing training and mentoring Safety team members.

• Experience in managing resource requirements and escalating concerns to senior management.

• Background in participating in audits/inspections, maintaining inspection readiness, and executing corrective and preventive actions.

• Minimal travel may be necessary.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Access to technical and therapeutic area training.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations provided when appropriate for employees or applicants with disabilities.