Clinical Safety Program Manager
23 hours ago
Job Summary:
We are seeking a highly skilled Clinical Safety Manager to join our UK team at Medpace, Inc. This role plays a key part in the pharmacovigilance process and is instrumental to the company's success.
Key Responsibilities:
- Manage clinical safety activities and multiple large programs
- Establish and maintain strong 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 thorough safety reviews of clinical study documents, including protocols, study reports, and marketing application components
- Create customized safety management plans based on client requirements
- Attend business development activities such as presentations to prospective sponsors, participation in sponsor audits, and generation of scope of work and cost estimates
- Develop departmental SOPs and Work Instructions
Required Qualifications:
- Bachelor's degree or equivalent and clinical safety experience, including project management and ideally line management experience
- Previous experience managing clinical safety activities for multiple programs
- Experience 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
$80,000 - $110,000 per year, depending on experience. Flexible work environment, competitive compensation package, structured career paths with opportunities for professional growth, and employee health and wellness initiatives make this an attractive opportunity. Our mission is to accelerate the global development of safe and effective medical therapeutics through our scientific and disciplined approach.
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