Clinical Safety Manager - Pharmacovigilance/Drug Safety

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Medpace

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.

Bachelor’s degree and 5 years of clinical safety experience, including project management and ideally line management experience; OR
Master's degree and 3 years of clinical safety experience, including project management and ideally line management experience;
Previous experience of managing clinical safety activities for multiple programs;
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.