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Clinical Safety Operations Manager
2 months ago
We are seeking a highly skilled and experienced Clinical Safety Operations Manager to join our team at Pharmiweb. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the safe and effective management of clinical trials and post-authorization studies.
Key Responsibilities- Develop and implement proactive safety strategies for assigned processes and delivery of operational safety aspects.
- Provide key expertise and guidance to Global Drug Safety functions and other functions within the company, as well as vendors for safety operational tasks.
- Accountable for the development, optimization, implementation, and documentation of appropriate processes to ensure Pharmacovigilance compliance in the area of responsibility.
- Define process KPls, implement, monitor, and communicate performance and develop solutions for continuous improvements.
- Ensure sponsor required compliance by vendors involved in clinical trials and non-interventional post-authorization studies in close collaboration with the Vendor Manager.
- Health Care Professional with extensive work experience in pharmacovigilance area, clinical development, project management, IT Systems.
- Fluent in written and spoken English.
- University degree is an advantage or relevant professional experience equal to scientific studies.
- Proven project and process management skills.
- Several years of professional experience (5-7 years) in Drug Safety/Clinical Trial Safety Management.
- Leading or attending Drug Safety Monitoring Committee meetings.
- Drafting and using ICF's.
- Sound understanding of regulations relevant to the safety of drugs in development and post-authorization.
- Excellent communication skills in an international environment.
- Intercultural experience through successful collaboration in matrix teams.
At Pharmiweb, we offer a competitive salary and a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a Global Employee Assistance Programme.
