Location: Stirling
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.
Benefits
* Flexible work environment
* Competitive compensation and benefits package
* Competitive PTO packages
* Structured career paths with opportunities for professional growth
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
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