Job Description

Qualified candidates must reside in Metro Atlanta, GA

SUMMARY

The Medical Information Specialist (MIS) is responsible for handling medical information, adverse events and/or product complaints on behalf of TMAC clients. The MIS will be trained in policies and procedures in accordance with FDA regulations as it relates to medical information, drug safety /surveillance, pharmacovigilance and product quality. The MIS is expected to develop a high level of expertise in these areas and is continuously aware of changes in these regulations.

The MIS will be trained in various disease states and products and be expected to maintain a high level of expertise in these areas as they relate to the daily activities of TMAC clients. In addition, the MIS will establish a high level of working knowledge about TMAC’s medical information databases. As requested, the MIS will contribute to development and set up of projects relating to programs within all departments at TMAC.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Handle phone and written disease state and product inquiries from physicians, other health care professionals, consumers and client sales representatives and client medical personnel according to client protocol.
• Review the client standard response database and/or the published literature to determine the best response. Industry “Best Practices” will be adhered to.
• Evaluate each medical inquiry to determine its legitimacy and its relationship to an adverse reaction and/or product complaint.
• If necessary, draft new medical letters in response to inquiries and for inclusion into the medical information database.
• Handle phone and written reports of adverse events and/or product complaints from physicians, other health care professionals, consumers and client sales representatives and client medical personnel.
• Manage adverse event and product complaint inquiries according to client standard operating procedures (SOPs), or TMAC SOPs if no client SOPs are in place.

QUALIFICATIONS

• BS Pharmacy, PharmD, BSN, MSN or PhD in life sciences
• Prior Industry experience or clinical practice experience required
• Excellent organizational skills
• Excellent communication skills
• Strong computer skills
• Familiarity with Drug Safety policies and procedures
• Bilingual a plus

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