Drug Safety Associate
Watson Pharmaceuticals - Morristown, NJ

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Assist the Director, Medical Affairs in managing the mandatory safety reporting requirements and other functions of the Drug Safety Group. Included in these functions are: Triaging, Data entry; Case processing; Creation of case reports; Submission of case reports;

Compilation of aggregated reports; Submission of aggregated reports and Special projects. Coordinating and performing the processing, and assisting in the collection and reporting of adverse drug experience (ADE) data in compliance with applicable FDA and global regulations and Company SOPs and guidelines.

Essential Functions and Responsibilities
· Perform accurate data entry of identified ADE information and ensuring the uniform and timely processing of ADE reports.
· Coordinate and assist in the collection and handling of product complaints and inquiries.
· Executes exchange of information with global counterparts (Pharmacovigilance Drug Safety Europe/ROW).
· Perform triage on all case types and determine labeling and case assessment to determine prioritization.
· Initiate critical follow up.
· Participates in the decision of upgrade and downgrade of cases after initial and follow up information.
· Create case narratives.
· Assist in the review of ADE information for completeness and consistency.
· Prepare and generate cover letter and ADE report in a MedWatch format for submission to regulatory authorities.
· Participate in the compilation of aggregate reports per US and international regulations.
· Consult/collaborate with internal colleague and external business partners to meet domestic and global regulatory reporting requirements.
· Participate in set-up and maintenance of ADE workflow, implementation of department policies, development and review of SOPs.
· Participates in training MA staff on Triaging, Case Processing, Case Review and Submission to FDA.
· Coordinate the department’s clerical workflow and assist with special projects as assigned.
· Maintain accurate, organized and up-to-date records of case contacts in the appropriate logbook (ADE, medical inquiry or product complaint).
· Coordinate with other departments to maintain work flow in MA in accordance with SOP guidance.
Qualifications
Specialized Knowledge and Skills · Knowledge of FDA and international ADE reporting regulations per International Conference of Harmonization (ICH) guidelines and the ability to interpret and apply applicable regulations to resolve issues.
· Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with applicable regulations.
· Experience with preparation of investigational and post-marketing regulatory reports.
· Proficiency with standard office skills, standard desktop computing programs, basic customer service principles, medical terminology and relational databases.
· Excellent oral and written communication skills. A pleasant phone personality for communications.
· Excellent interpersonal skills and willingness to work in a team environment.
· Demonstrates consistent attention to detail.
· Highly organized and demonstrates understanding of workflow prioritization.
· Ability to multitask and triage as necessary.
· Project management experience desirable.
· For medical management module, medical background or equivalent and experience in data analysis and medical evaluation of safety data.
· Performs ADE data entry into the applicable case form and log books, and when available, global safety database.
· Performs the processing defined work flow steps of ADE information received by DSG, and the preparation of internal and external reports under supervision.
· Writes case narratives under supervision.
· Assists in the review of ADE information received by DSG for completeness and consistency.
· Participates in the compilation of aggregate reports per US and international regulations under supervision.
· Participates in special projects as assigned.
· Working knowledge of scientific terms and medical terminology.
Equipment and Applications · Working knowledge of MedDRA.
· Excellent computer skills including Microsoft Office Application
Education
· BS degree in healthcare-related field or equivalent.
2-5 years of safety related experience

Watson Pharmaceuticals - 18 months ago - save job - block
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