Summarized Purpose :
Provides technical and medical information, and / or performs intake of adverse events / product complaints with quality customer service.
Analyzes and researches inquiries and documents interactions according to organizational, client and regulatory guidelines.
The information provided will be given to a level in parallel with the individual’s expertise, experience and training.
Essential Functions :
Responds accurately and professionally to technical and medical information inquiries received via phone, email, internet or mail in reference to pharmaceutical or device products.
Processes fulfillments and provides clinical trial information or after-hours on call support.
Analyzes caller’s questions to formulate an accurate and concise response using client-approved resources and records inquiries and interactions in the appropriate databases following organizational, client and regulatory guidelines.
Identifies, records and triages adverse events and product complaints according to organizational, client and regulatory guidelines and provides additional support (including follow up) as needed.
Maintains thorough knowledge of project and corporate policies and procedures including client products, SOP's, protocols, GCP's, and applicable regulatory requirements.
Works closely with internal and external client contacts (up to and including members of client management) to resolve complex inquiries.
As needed, researches medical literature and drafts responses for such inquiries.
Education and Experience :
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
Some countries (e.g., Mexico) may require a health care professional degree or Medical information experience.
Knowledge, Skills and Abilities :
Excellent verbal and written communication skills
Excellent language skills (comprehension, speaking, reading and writing); Fluency skills in a second language may be required
Proficient computer and keyboarding skills
Good interpersonal skills
Ability to work independently as well as part of a team.
Ability to interpret client provided complex medical and technical information
Organizational and time management skills
Ability to maintain a positive and professional demeanor in challenging circumstances
Management Role :
No management responsibility
Working Conditions and Environment :
Work is performed in an office environment with exposure to electrical office equipment
Constant interaction with clients / associates required
Constant attention to detail-visual, mental
Daily exposure to high pressure, intense concentration needed
Rotating shifts may be required
Occasional driving to site locations with occasional travel
Long varied work hours required occasionally
Physical Requirements :
Frequently stationary for 6-8 hours per day
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
Occasional mobility required
Occasional crouching, stooping, bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. or 6-9 kgs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
Frequently interacts with others to obtain or relate information to diverse groups.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
Requires multiple periods of intense concentration.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
Ability to perform under stress
Regular and consistent attendance