Clinical Safety Manager - Pharmacovigilance/Drug Safety

Medpace

Stirling, United Kingdom

Job Summary

Our European activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Manager to join our UK team and to be based at our growing UK office in Stirling. This position plays a key role in the pharmacovigilance process at Medpace. Working in a team to accomplish tasks and projects that are instrumental to the company’s success.

If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

Manage Clinical Safety activities and multiple large programs;
Manage relationships with clients and internal stakeholders by providing expert safety knowledge;
Oversee clinical safety case management and aggregate reporting responsibilities to ensure client needs are fulfilled to a high quality;
Provide safety review of clinical study documents, including protocols, study reports; and marketing application components;
Create safety management plans dependent upon client;
Attend business development activities such as presentations to prospective Sponsors, participation in Sponsor audits, generation of scope of work and cost estimates;
Write departmental SOPs and Work Instructions.

Qualifications

Bachelor’s degree or equivalent and clinical safety experience, including project management and ideally line management experience;
Previous experience of managing clinical safety activities for multiple programmes;
Experience in writing departmental SOPs and Work Instructions;
Experience in PSMF generation and maintenance;
Experience in CCDS/RMP/SmPC writing and maintenance;
Comprehensive knowledge of global clinical safety regulatory requirements;
Excellent verbal and written communication skills;
Strong leadership, mentoring, and motivational skills;
Exceptional teamwork skills;
Ability to work independently.