Clinical Safety Manager - Pharmacovigilance / Drug Safety

				Overview:

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

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.
			

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