Manager, Safety & PV – Data Management Oversight

🔥 4 minutes ago

🇧🇬 Bulgaria – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Manage staff, including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, timesheet approval, and employee counseling • Advise staff on administrative policies, procedures, technical problems, and prioritization • Assign project work and review workloads for direct reports • Provide oversight and guidance on organizational goals and company objectives • Ensure data is accurate, complete, conform, consistent, current, and available to relevant stakeholders • Analyze complex data services in bulk, including mapping, enrichment, and cleansing • Coordinate services with IT teams, data governance, and data management workstreams • Monitor quality and efficiency against contracted scope of work and Safety Management Plans • Manage projects where Safety and Pharmacovigilance are the primary services • Review study budgets and expenses and uphold contractual and budgeting requirements • Coordinate customer invoicing with Finance; approve project time cards and invoicing • Provide sponsors with scheduled project updates and reports • Coordinate safety reporting reviews, submissions, document resolution, and issue resolution with internal departments • Participate in Safety and Pharmacovigilance departmental management and SOP development • Evaluate and improve departmental processes and functions • Represent Safety and Pharmacovigilance in project team and client meetings • Review clinical safety sections of study protocols and CRFs for consistency with Serious Adverse Event forms • Prepare and deliver training to Safety team members and other departments; mentor team members • Manage resourcing needs and escalate issues to senior management • Participate in audits and inspections, quality investigations, and corrective and preventive action implementation

🎯 Requirements

• Experience and expertise in safety and pharmacovigilance data management oversight • Experience with complex data services, including mapping, enrichment, and cleansing • Knowledge of quality assurance and data governance • Experience with service coordination across IT teams, data governance, and data management workstreams • Experience with performance management, reporting, KPI compliance, and invoicing • Experience managing Safety and Pharmacovigilance projects • Knowledge of study budgets, expenses, contractual, and budgeting issues • Knowledge of safety reporting processes and documents • Understanding of clinical safety sections of study protocols and Case Report Forms (CRFs) • Compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans, and the drug development process • Ability to develop, review, and approve departmental SOPs • Ability to review and execute Safety Management Plans/Safety Reporting Plans • Ability to identify process improvements and recommend changes • Ability to provide training and mentor Safety team members • Experience managing resourcing needs and escalating issues to senior management • Experience participating in audits/inspections, maintaining inspection readiness, and implementing corrective and preventive actions • Minimal travel may be required • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations, when appropriate, for employees or applicants with disabilities