Safety Manager, Drug Safety is part of the Project Delivery organization and is responsible for management in Drug Safety/Vigilance and will work according to company policies, SOPs and regulatory requirements
Key responsibilities include:
Responsible for monitoring the regulatory environment for changes that may have an impact on pharmacovigilance process. Drive best practices and excellence in execution within the safety department and cross-functionally.
Overview of quality and compliance metrics Key performance Indicators (KPIs), CAPA and deviation related to safety management.
Establishment and maintenance of Pharmacovigilance System Master File (PSMF).
Drive the internal impact analyses of new/updated guidelines and legislation, development of strategies and drive for appropriate action(s) relevant to safety projects.
Handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the TFS/clients’ SOPs and existing regulatory demands.
Review and approval of processed cases, AE/SAE reconciliation and safety coding.
Responsible for plans/instructions and SOPs for post approval surveillance.
Overlook that assigned projects and tasks in the unit are performed in accordance with current routines, methods, SOPs (TFS or client´s) and current legal requirements.
Lead relevant project groups/meetings.
Initiate and lead internal improvement project with other relevant departments.
Actively contribute to the organization and development of routines/processes to enhance the work at TFS.
Responsible for the updates of templates for safety handling in specific studies/projects according to relevant SOPs.
Ensure that new processes are implemented within the unit.
Being well-informed and updated on regulations, directives and guidelines concerning handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues.
Responsible for the education and supervision of new Drug Safety personnel.
Bachelor’s Degree, preferably in life science or nursing; or equivalent.
3-5 years of relevant Drug Safety experience.
Able to work in a fast-paced environment with changing priorities.
Understand the medical terminology and science associated with the assigned drugs and therapeutic areas.
Understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs.
Ability to work independently as well as in a team matrix organization with little or no supervision.
Excellent written and verbal communication skills.
Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus.
Demonstrate ability to lead, mentor, educate and supervise Drug Safety personnel.