Manager, PV Safety Writing
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Job Location:
Monthly Salary:
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
OfficeJob Description
Join us as Safety Writing Manager And lead the efforts in managing and optimizing drug safety operations to ensure the highest standards of patient safety and regulatory compliance in clinical trials.
What Youll Do:
Manage the delivery of global aggregate safety reports risk management plans (RMPs) regulatory authority assessment report responses and custom safety reports for both developmental and marketed products.
Ensure that the team is provided with sufficient resources to deliver services in accordance with company policies and procedures contractual agreements and applicable regulations.
Maintain good communication with other functional groups concerning safety writing activities. Prepare for and present proposals and bids on behalf of the Safety Writing Team.
Prepare for and contribute to client and internal meetings audits and regulatory authority inspections.
Participate in departmental initiatives and task forces for process improvement and overall department management.
Review regulatory/pharmacovigilance publications and information sources to keep updated on current regulations and practices.
Provide input on PV procedural documents.
Participate in meetings to communicate quality budgetary or operational information in relation to safety writing services.
Manage staff of experienced professionals which may include interviewing and selection job description preparation professional development goal setting performance management coaching and mentoring employee counseling and separations. Approve courses of action on salary administration hiring corrective action and terminations. Review and approve time records expense reports requests for leave and overtime.
Education and Experience:
Bachelors or higher scientific degree
Previous safety writing experience to provide the knowledge skills and abilities to perform the job (> 5 years).
1 year of leadership responsibility
In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge Skills and Abilities:
Excellent knowledge of risk management plans and ICH and US aggregate safety reporting formats relating to both clinical trials andmarketed products
Excellent attention to detail data interpretation and medical-scientific writing skills
Time management and project management skills
Proficient in Microsoft Office products and safety databases
Excellent oral and written English language communication skills
Strong attention to detail and accuracy
Strong critical thinking problem solving and decision making skills
Advanced understanding of the global regulatory requirements pertaining to pharmacovigilance andthe importance of and compliance with procedural documents and regulations
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment
Daily exposure to high pressure and intense concentration
Daily interactions with clients/associates
Long varied hours on occasion
Travel required occasionally domestic and/or international
Why Join Us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experience and where your contributions truly make a difference.
Apply today to help us deliver tomorrows breakthrough.
Required Experience:
Manager
Key Skills
- Quality Assurance
- Construction Experience
- Food Safety Experience
- Management Experience
- Root cause Analysis
- Risk Analysis
- OSHA
- EPA
- HACCP
- Product Development
- EHS
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
