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* PLEASE NOTE: THIS ROLE MAY ASSIGN JERSEY CITY, NJ or BRIDGEWATER NJ AS PRIMARY WORK LOCATION*
The Drug Safety Associate is responsible for the collection, data entry, routing, follow-up, and timely
reporting/submission of safety information (including expedited and aggregate reports) related to Company products
from a variety of sources (clinical trial, spontaneous, literature), both U.S. and Rest of World, in compliance with
Company SOPs, US regulations, and international regulations. This position is also responsible for self-initiated quality
review within each distinct process step.
1. Receive and investigate incoming post-marketing event reports from internal and external (foreign and domestic)
2. Verify the presence of all information constituting a case (product, reporter, event, and patient), collect the clinical
details describing the event(s), and identify duplicates. Request critical missing information for non-cases by
expeditiously contacting the reporter.
3. Assemble/update the electronic case folder based on the specific characteristics of the case (e.g. event, reporter,
medical assessment, reportability, country of origin, etc.).
4. Perform in process QC for case receipt.
5. Support Safety Information Specialists in pre-screening literature information.
6. Triage the case based on seriousness, method of receipt, literature translation status, narrative requirements,
potential legal implications, associated product complaints, and the potential need for manual coding.
7. Draft a follow-up query/letter (including Clinical Development Input Form for clinical trials) for reports needing
8. Contact Professional Affairs for medical/product questions, Customer Service for product reimbursement, Quality
Assurance for product complaints, and other pharmaceutical companies in the case of a co-suspect drug.
Case Entry Review
9. Enter unstructured case data into safety database, verify coding, and complete narrative description of the
experience (including Clinical Development Input Form for clinical trials).
10. Finalize follow-up queries, as necessary.
11. Perform quality review for case entry.
12. Review and refine narrative, include source document review, verify coding, and perform in process quality review
for case review.
13. Advance serious or event of interest cases medical review.
14. Identify cases as unblind when applicable and requiring output for analysis of similar events.
15. Based on information provided by the Safety Physician, make modifications as instructed (e.g. coding) and
perform in-process quality review.
16. Perform quality check of individual case safety reports.
Submission and Distribution
17. Generate and send a follow-up letter/queries to the appropriate reporter using the most expedient mechanism,
forwarding to Legal, Quality Assurance, and/or Associated Business Partner where appropriate.
18. Support Safety Information Coordinators in appropriately issuing notifications to Legal, Quality Assurance, and
co-suspect drug companies per standard operating procedures.
Healthcare professional with a BA/BS degree in pharmacy or nursing or with equivalent experience is required
MA/MS or PharmD degree in pharmacy or nursing is a plus
Min. 1 year of experience in the pharmaceutical industry preferred
At least one year experience in Pharmacovigilance is preferred
Familiarity with medical and clinical terminology, MedDRA, and drug safety databases (eg, Clintrace, Argus, or
ARISg) is essential
Knowledge, Skills, and Abilities
Clinical investigative/inquiry skills and knowledge of the etiology of disease
Familiarity with U.S. Code of Federal Regulations and international regulations regarding AE reporting
Knowledge of Pharmacovigilance processes, standards, and conventions
Familiarity with safety information including CIB, SmPc, and USPI
Safety database knowledge is required: ARISg experience and navigation skills preferred, Ag Xchange is a
Proficiency with Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, and Adobe Acrobat
Must possess excellent skill/ability in the following:
Oral and written communication with clear professional expression on paper
Advanced telephone etiquette and telephone interviewing skills
Planning and Organizing
Decision Making, Judgment, and Problem Solving
Initiative and Accountability
Training and Mentoring new employees as needed
EOE Statement EOE Minorities/Females/Protected Veterans/Disabled
Equal Opportunity is the Law poster: English