Manager Drug Safety and Pharmacovigilance Operations Job in Raleigh 27604, North Carolina US
job ID: 8434
Position Title: Manager Drug Safety and Pharmacovigilance Operations
Working Location: US, Raleigh, NC
Employment Status: Full-Time Regular
Required Experience: 3 years
Required Education: Bachelors Degree
Required Travel: 0
Job Summary:
Manages Drug Safety and Pharmacovigilance Operations staff members. Participates in process development, budget reviews, and project management. Ensures consistency and communication between the Drug Safety Case Managers (DSCMs) and Safety Coordinators/Safety Specialists (SCs/SSs)
Core Responsibilities:
1. Line management responsibilities including professional development, performance appraisals, and employee counseling for junior staff. Assigns project work and reviews workload for all direct reports. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level. Monitors the quality of work and efficiency of team members.
2. Serves as functional lead for projects in Drug Safety and Pharmacovigilance Operations which contain no aspects of Drug Safety Case Manager’s services. Works with Project Managers and/or sponsors to clarify safety reporting responsibilities. Attends bid defenses as needed.
3. Serves in Project Manager role on projects where Drug Safety and Pharmacovigilance are the primary services.
• Reviews study budgets and expenses, and ensures all study related contractual and budgeting issues are upheld and performed. Submits time cards as necessary.
• Works with Finance to ensure appropriate customer invoicing.
• Approves project time cards, backlog, and invoicing.
• Provides sponsors with scheduled project updates and reports.
4. Maintains certification to register sponsors and/or products and for electronic reporting in the EudraVigilance safety database system.
5. Participates in the management of the Drug Safety and Pharmacovigilance department with the following actions:
• Assists in the review and approval of departmental Standard Operating Procedures (SOPs).
• Evaluates processes for potential improvement in efficiency and effectiveness, and recommends changes. Participates in process development and improvement of departmental functions.
• Assists with or oversees periodic review of budgets for ongoing full service projects to determine financial status and follows up with Project Management when needed.
Performs other work related duties as assigned. Maintains understanding of SOPs, WIs, global drug/biologic/device regulations, GMP, ICH guidelines and the drug development process. Acquires basic understanding and maintains knowledge of ongoing protocol and disease related terminology. Minimal travel may be required (up to 25%).
Skills Attributes:
Requires B.A./B.S. in the science/health care field, nursing degree or equivalent combination of education and experience and nominal clinical research/drug safety experience and demonstrated leadership skills. . Experience in a Clinical Research Organization and with INCR’s therapeutic specialties is preferred. An understanding and working knowledge of financial budgets and various financial analysis tools is preferred. Flexibility and the ability to work in a matrix environment required. Ability to handle multiple tasks while delivering high quality work is essential. Excellent communication skills (verbal, written and graphic) are required. Requires strong presentation skills, interpersonal skills, as well as a team oriented approach. Superior computer skills in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project), e-mail, and internet are required.
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