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Drug Safety Specialist Job
Eingestellt von Yoh
Gesuchte Skills: Support, Client
Projektbeschreibung
The Big Picture - Top Skills Should You Possess:
- Drug Safety
What You'll Be Doing:
- Execute receipt of Drug Safety phone calls and complete telephone AE form
- Create phone call communication logs in ARISg
- Support the triage of cases conducted by Senior Specialist as needed
- Execute QC on key fields of serious cases
- Create key fields updates in ARISg based on QC, as needed
- Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
- Create narratives as needed
- Review and update auto-narrative as needed
- Create draft company comments for serious cases
- Develop event rankings
- Create dechallenge/rechallenge determinations
- Develop follow-up needs for AE reports
- Create targeted follow-up letters
- Review and update generated follow-up letters as appropriate
- Authorize (approve) non-serious cases
- Create major modifications following Medical Review
- Support the identification of corrections and creation of updates in ARISg following medical review
- PHARMACOVIGILANCE (APPROVED PRODUCTS)
- PSURs
- Update AE reports within safety database to support line listings
- Preparation for Regulatory Inspection
- Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
- Participate in team meetings within the drug safety department
- Contribute to the orientation and training of staff as needed.
What You Need to Bring to the Table:
- Healthcare professionals (RN, PharmD) preferred.
- Must be able to produce a high volume of high quality cases within a busy Drug Safety work environment.
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Hannah Cihlar
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: HC
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Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Berkeley Heights, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges