Drug Safety Specialist

MedAssessment, Inc.; United States; Remote; USD 80,000 - 115,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Drug Safety Specialist to evaluate and process safety reports. The role involves managing case safety reports, conducting quality checks, and ensuring compliance with regulatory standards. Ideal candidates will have a background in nursing or a related medical field, along with strong pharmacovigilance knowledge.

Qualifications

• Requires a Bachelor's degree in nursing or related field.
• 2-4 years experience in drug safety or related field.
• Strong writing and analytical skills are essential.

Responsibilities

• Review and process individual case safety reports.
• Enter and verify data accuracy in safety databases.
• Conduct quality checks and liaise with clients.

Skills

Medical writing

Data analysis

Pharmacovigilance knowledge

Independent medical judgment

Database management

Education

Bachelor's degree in nursing or physician assistant program

Tools

Safety database software

Microsoft Office

Job description

This range is provided by MedAssessment, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$80,000.00/yr - $115,000.00/yr

General Summary:

Responsible for reviewing, evaluating and processing individual case safety reports received from a wide variety of sources. This includes coding relevant medical terms, assessing expectedness, and causality, writing/reviewing/editing the narrative including Sponsor comments, generating and tracking queries, performing quality checks, and preparing cases for lock and submission, while ensuring reports are submitted within required timelines.

Essential Duties and Responsibilities

• Receives assigned individual case safety reports and follow-up information via safety inboxes, emails, faxes, or safety software. Prioritizes work processing to meet internal processing requirements as well as client and regulatory requirements and deadlines.
• Creates a case or updates the Safety Database with the new information to ensure a complete and accurate record of the event in accordance with the client protocols and specifications. This includes entering available demographic information, study drug(s), concomitant medications and medical history for that subject. If needed, QC check of data entered by client or client’s representative.
• Reviews subject data in client’s electronic data capture software to ensure the data is complete and accurate in the safety database and reports.
• Reviews medical records and other documentation to identify relevant data missing from the case. Enters such data into the safety database. Codes adverse events in accordance with accepted pharmacovigilance practices.
• Creates and sends queries to investigator sites to clarify data sent or request additional or missing data needed to complete the safety assessment of the adverse event.
• Writes and or edits narratives in a manner consistent with regulatory requirements for submissions describing the medical event as well as the relevant history.
• Makes initial assessments of expectedness and causality of the adverse event which requires using considerable judgment based on sound medical knowledge and experience.
• Reviews and/or corrects the narratives including the writing of the initial Sponsor comments regarding causality, expectedness and listedness.
• May be required to check the quality of the cases processed by other first reviewers as part of a client’s on-going quality review program.
• Participates in meetings with other MedAssessment staff and/or with client staff to discuss specific case issues as well as the general processes required to meet obligations.
• Participates in ongoing training and development by reviewing client documents, participating in training sessions and keeping abreast of current policies and procedures. Participates in on-going training sessions as needed.
• Keeps medical and pharmacovigilance knowledge up-to-date through reading and attendance at seminars and conferences.

Required Knowledge Skills and Abilities

• Requires the knowledge of medical care equivalent to that normally acquired through the completion of formal education in medicine such as a Bachelors’ degree in nursing or a physician assistant program and two to three years of direct patient care experience.
• Requires the knowledge of pharmacovigilance equivalent to that normally acquired with two to four years of experience in drug safety.
• Strong medical writing skills with the ability to craft written narratives for adverse events for a patient in a format consistent with the clients’ desires, and regulatory requirements.
• Requires independent medical judgment in order to assess the relevance of patient data to be included or excluded in the safety review of each case and to make recommendations to the Medical Reviewer and client.
• Maintenance of knowledge of the qualifying discipline and pharmacovigilance.
• Competent knowledge of appropriate safety database software in order to process cases in a timely manner with high quality, as well as a functional knowledge of accepted medical coding and drug identification software such as MedDRA and WHODrug.
• Knowledge of common office software including Microsoft Office and related office programs.
• Ability to work independently in a remote location.

Working Conditions

• Works is a normal home office environment with few, if any hazardous conditions.
• Requires extensive periods of computer work with requisite eye strain and discomfort of sitting for long periods. Has the ability to move about as needed.
• Some, but infrequent travel maybe required for Company and/ or client meetings.

The information provided in this job description is intended to describe the general nature and level of work expected to be performed by the people assigned to this job. This document is not meant to be an exhaustive list of all duties, accountabilities, skills and working conditions associated with this job.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Pharmaceutical Manufacturing

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