Manager, Med Info and Safety
One of the largest CROS in the global market is currently recruiting a Manager, Med Info and Safety to their office in Poland. This contract research organisation (CRO) is renowned for their work in technological advances and access to real-world data. This is an exciting opportunity to become embedded in the wider clinical operations team and work on ground-breaking new medicine development.
- Manage PhV staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems.
- Approve actions on human resources matters.
- Monitor and motivate staff to achieve and maintain acceptable levels of performance.
- Work closely with other department managers to address problem areas, staffing needs, equipment needs, and department resource planning and work scheduling for current and projected projects to ensure deliverables are met.
- Ensure that staff have been trained on and are following Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), FDA and ICH guidelines and regulations, Working and Project Instructions.
- Lead and encourage direct reports in continuous improvement of department work processes and infrastructure. Instruct and lead direct reports in efficient management of project budgets.
- Monitor with Program Managers and overall Pharmacovigilance management to ensure that department deliverables meet expected quality, financial and productivity targets. Work with Pharmacovigilance management to ensure department realization and utilization targets are met. Ensure department metrics are collected and meet expected targets.
- Assure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA regulations and guidelines, working instructions and client expectations.
- Assure that, within the functional group assigned, SOPs and Work Instructions are appropriate and current, and that personnel are trained accordingly.
- Facilitate, develop and implement plans for measuring and improving employee engagement.
Skills and Requirements:
- Bachelor's degree or educational equivalent in health science or other directly related field.
- 5 years of clinical research experience in a Contract Research Organization or Pharmaceutical, company including 2 years management experience; or equivalent combination of education, training and experience.
- Extensive knowledge of Pharmacovigilance and safety surveillance.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Divya Mistry at +44 20 3814 1315 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Highly Competitive Salary
Proclinical is currently seeking a PV Operations Manager for a pharmaceutical company located in Cambridge, MA.