Company: Labcorp Drug Development
Post: Drug Safety Associate
Qualification: Lifesciences graduates
Location: Japan
Experience: Freshers and experienced
Post: Drug Safety Associate
Qualification: Lifesciences graduates
Location: Japan
Experience: Freshers and experienced
Job Overview
- Manage the receipt, processing and quality review of expedited safety reports (ESRs) to Japan PMDA. This includes, but is not limited to
- maintenance of adverse event tracking systems
- set-up and maintenance of project files, core process files and central safety files
- contact with Regulatory Authorities, project teams and with clients to support safety reporting activities
- 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 Labcorp project personnel, if required, within study specified timelines
- Assist in the preparation of listings for Annual IND reports Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).
- Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting.
- Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact Safety.
- Build and maintain good PSS relationships across functional units.
- Demonstrate role-specific Competencies on a consistent basis.
- Demonstrate company values on a consistent basis.
- Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
- Assist in the coordination of endpoint committees, as required.
- Any other duties as assigned by management.
Required
Education/Qualifications:
- 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.
- 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.
Experience
- A high degree of accuracy with attention to detail.
- Functions as a team player.
- Good Communication in both Japanese and English.
- Knowledge of medical and drug terminology is desirable.
- Familiarity with Good Clinical Practice (GCP) related to clinical safety documentation.
- Familiarity with ICH Guidelines
- Familiarity with worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products.
- Familiarity with worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products.
- Good written and verbal communication skills.
- Ability to work independently with moderate supervision.
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
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