Post: Senior Associate, Drug Safety
Job Description:
• Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
• Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
- entry of safety data onto adverse event database(s) and tracking systems
- review of adverse events for completeness, accuracy and appropriateness for expedited reporting
- write patient narratives
- code adverse events accurately using MedDRA
- determine expectedness/listedness against appropriate label
- identifies clinically significant information missing from initial reports and ensures its collection
- ensure case receives appropriate medical review
- prepare follow-up correspondence consulting the medical staff accordingly.
- ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
- reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
Candidate Profile:
• Non-degree + 4-5 yrs relevant experience (or 2 yrs safety experience)*
• Associates Degree + 3-4 yrs relevant experience (or 1-2 yrs safety experience)*
• Associate degree RN + 2-3 yrs relevant experience (or 1-2 yrs safety experience)*
• BS/BA + 1-2 yrs relevant experience**
• MS/MA + 0 yr relevant experience**
• PharmD + 0 yrs relevant experience**
• Non-degree + 4-5 yrs relevant experience (or 2 yrs safety experience)*
• Associates Degree + 3-4 yrs relevant experience (or 1-2 yrs safety experience)*
• Associate degree RN + 2-3 yrs relevant experience (or 1-2 yrs safety experience)*
• BS/BA + 1-2 yrs relevant experience**
• MS/MA + 0 yr relevant experience**
• PharmD + 0 yrs relevant experience**
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
Experience:
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
*Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
*Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
Additional Information:
Requisition ID: 59013BR
Location: India
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Clinical Research
Requisition ID: 59013BR
Location: India
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Clinical Research
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