Medical Safety Specialist
Fort Worth Metro Area, Texas
Complaint handling accountabilities reflect activities required to comply with local and international regulations, guidelines, and applicable directives.
Manages quality and adverse event complaint records for assigned therapeutic area(s) using designated safety system(s)
Reviews potential complaint data received via safety system(s), phone, fax, mail, or other methods
Creates/completes complaint records according to established guidelines
Performs/coordinates follow-up to obtain missing and additional information and/or samples
Documents additional information upon receipt (i.e. correspondence, medical records, service requests ..)
Reviews investigation findings when complete
Reviews and closes files according to established guidelines to meet required timelines
Provides support for: internal and external audit activities, preparation of aggregate reports, responding to follow-up questions from regulatory agencies.
Maintains a working knowledge of: company policies and procedures, departmental processes, and associated work instructions, evolving local and international regulations, guidelines and applicable directives , products for assigned therapeutic area(s) and corresponding documentation (Product Inserts, DFUs, Manuals, Promotional Materials), eye anatomy, common diseases, ophthalmic evaluation procedures, eye terminology and abbreviations, safety databases(s) and reporting tools
Informs management of potential safety issues, emerging trends and/or concerns
1-3 years relevant work experience (i.e. device/drug safety, compliance, quality assurance, regulatory affairs)
3-5 years clinical experience ophthalmology preferred
Customer Service Experience is a plus
Ability to effectively present information and respond to questions from groups of managers, clients, and customers.
Strong work ethics, ability to manage change, ability to organize complex work, conduct problem solving.
Excellent time management and prioritization skills
Task and detail-oriented
Ability to work in a global cultural environment
Computer proficiency (data entry, retrieval and analysis)
Excellent written and verbal communication skills
Sensitive to confidentiality of data
Self-directed and self-motivated.
Ability to perform under pressure and meet strict timelines