Drug Safety Scientist Resume Example

• Administrate the day to day dealings of 6 independent ASI business consultants.
• Ensure that sales goals are met.
• Set competitive price points.
• Keep abreast of current and effective trends in all industries.
• Schedule training and continued education for ASI consultants.
• Provide training and support in the following services that our company provides

    • Subject matter expert for all Medical Inquires (MI), Adverse Event (AE), Product Complaint (PC) calls.
    • Ensure complete and accurate data intake function regardless of channel of communication specified by client.
    • Evaluate and process AE and PC in accordance with GMP and FDA regulations.
    • Respond to MIs from HCPs and consumers on client's products.     
    • Provide evidence-based information to decision-makers to assist with the proper use of client products.
    • Provide answer to “on-label” inquiries using FAQs and PIs.
    • Diffuse dissatisfied or hostile callers.
    • Respond to media crisis and/or product recalls involving client's products.
    • Manage high workload volume.
    • Prepare the phone reconciliation report, and MCC metrics reports.
    • Data entry of AE cases into the  including initial case book in and data entry/investigation.
    • Provide superior customer service while maintaining 100% compliance.
    • Case processing for AEM Clients for up to 4 hours a day,including follow up action items.
    • Assist in development, updating and maintaining MCC procedural documents.
    • Participate in quality assessment reviews and audits
    • Mentoring, training, and updating of new and existing staff on clients.
    • Precept PharmD students.
    • Mentor Medical Communication Center Resident.
    • Assist the Medical Communication Team Lead during implementation of new Clients.
    • Knowledgeable GMP/FDA regulations, and client specific issues.

• Develop a high level of familiarity and knowledge of Phase I-IIa clinical trial study protocols and flow chart of study procedures.
• Develop a strategy for implementing study procedures in compliance with the study protocol.
• Perform study protocols (e.g., IV Start, blood draws, obtain biological specimen samples, obtain ECG recordings, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Clinical Research Coordinator, Principle Investigator, and Sub Investigators.
• Monitor and treat clinical trial subjects for any adverse events (e.g., anaphylaxis, cardiac/respiratory arrest, infiltration, thrombophlebitis, etc.), documenting relevant data and expediting the reporting of serious adverse events to the study sponsor.
• Record study data in source documents.
• Evaluate and review study data to ensure accuracy and completeness.
• To liaise with sponsor personnel, to maintain a high level of professional expertise through familiarity with the study protocol, investigator's brochure, and related study materials, and to participate in project team meetings.

• Managed an account base of 1500 Dunn & Bradstreet rated companies.
• Achieving over $1 million of sales revenue to surpass annual forecast on a regular basis.
• In an outbound call environment, servicing the customers' needs for promotional items by following prescribed sales processes to discover the need, present promotional products as solutions to those needs, overcome objections, close the sale and ultimately build lasting customer loyalty.
• Solicit referrals from established customers and make follow up calls on free promotional samples sent via business reply mail to replenish and increase client base, develop new customer relationships and loyalty.
• Facilitate product replacements, credits and handle all aspects of customer service for my customers.
• Promote and represent a positive and professional corporate image of my employer to the customers.
• Act within the scope of my authority and be consistent within company objectives, guidelines and policies.
• Make recommendations for improving quality products by advising of any order trends, complaints and competitor information on an on-going basis Attend required and elective training classes on a regular basis to increase competency.