Job Opening

Director, Pharmacovigilance and Medical Information

About PROSAR

PROSAR Drug Safety Call Center is located in St. Paul, MN. We are a leading provider of drug safety call center services to the pharmaceutical and dietary supplement industries. PROSAR provides a complete post-marketing surveillance program including adverse event processing, medical information services, product complaint documentation and safety reporting to FDA.

Basic Position Functions

Participate in the coordination, development, and maintenance of all aspects of PROSAR's pharmacovigilance and medical information services on a daily basis. Hire, train and supervise PV&MI staff. Participate in case management process and provide assessment and final approval of individual AE case reports and periodic reports. Act as main client contact for select client companies.

Examples of Work Performed

• Manage and supervise PV&MI staff.
• Plan and coordinate work assignments to ensure that all timelines are met..
• Participate in development of policies, procedures and processes.
• Ensure all PV&MI staff is properly trained for assigned functions. Identify training needs, develop training materials, execute training presentations and on-the-job-training for new and existing PV&MI staff.
• Provide case assessment and final review and approval of individual AE case reports and periodic reports.
• Participate in case management and assist staff with case management.
• Participate in recruiting, interviewing and hiring of staff.
• Act as a main client contact, implement new client companies, maintain communication with client companies, address and resolve process- and case-related issues.
• Assist sales with presentations to pharmaceutical and dietary supplement companies.
• Other duties as assigned

Degree Requirements

• Pharm.D. or B.S. in Nursing (or equivalent)

Other Requirements

• Hands-on experience in safety reporting for drugs or devices of at least 2 years
• Clinical work experience in a hospital setting of at least 2 years
• Drug Information experience
• Experience managing staff
• Excellent oral and written communication skills
• Excellent attention to detail

Desired

• Pharmaceutical Company experience
• Call Center experience
• Experience working with Oracle AERS
• Experience interacting with partner or client companies
• Project management experience

Licensure Required

• MN License appropriate with degree or equivalent from another state or country must be maintained

If you are interested in this opportunity with PROSAR, please send your resumé to .

Download a printable PDF of this job description. (32K PDF)

PROSAR – Confidential and Proprietary