The Manager, Safety and Pharmacovigilance is responsible for oversight of global safety submissions, including expedited report to Regulatory Authorities, Ethics Committees and Investigator sites; for maintaining compliance metrics; implementing Preventative and Corrective Actions following quality issues;
Roles and Responsibilities:
- Monitor global PV regulations
- Implementing Regulatory compliance
- Ensures oversight and monitoring of key global regulatory requirements and their implementation
- Defines and introduces standards for metrics to measure compliance according to regulations, SOPs, work instructions, procedures.
- Drives process improvement initiatives;
- Performs training for safety staff and other key stakeholders involved with safety submissions
- Ensures generation of consistent and accurate compliance reports for Senior Management.
- Evaluates and monitors the effectiveness of existing metrics
- Management of Safety & PV Submission Specialists responsible for performing safety submissions
- Reviews Safety Management Plans and Safety Reporting Plans to ensure accuracy
- Performs budget review related to submission costings
- Represents SPVG at Bid Defense meetings/ Sponsor meetings/audits in relation to safety submission tasks.
- EudraVigilance User and submit reports
- May act as Responsible Person/Trusted Deputy for EudraVigilance
- Oversee global CAPAs, related to safety submissions ensuring compliance with commitments and including assessment of root cause.
- BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience
- Progressive responsibility with demonstrated leadership skills and project management
- Clinical Research Organization (CRO) experience with therapeutic specialties preferred
- Working knowledge of financial budgets and various financial analysis tools preferred
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet
- Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills
- Ability to establish effective relationships with clients as well as team members
- Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment
- Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment
- Experience in performing and monitoring compliance of global safety submissions
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. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.