Drug Safety Specialist

Job Location(s) JP-Tokyo
Job Number
Job Category
Drug Safety/Pharmacovigilance
Position Type

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 Covance project personnel, if required, within study specified timelines
- provide independent QC of AE reports for other members of the group
- May execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.
- Maintain a strong understanding of Covance’s safety database conventions or client-specific database conventions, as appropriate.
- Participate in signal detection, trend and pattern recognition activities, as appropriate.
- Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR) Periodic Reports (PRs) line listings, and aggregate reports.
- Begin to participate and demonstrate leadership on projects which enhance team and/or division performance. This includes acting as a lead contact for projects including global projects ensuring communication and process harmonization.
- Work with Data Management or client on reconciliation of safety databases, if appropriate.
- Monitor workflow for assigned studies/programs to ensure all deadlines are met.
- Draft/modify and deliver safety presentations
- Serious Adverse Event reporting at Investigator meetings
- Client capabilities meetings, as appropriate
- “Department Overview” to internal clients
- Maintains a comprehensive understanding of Covance PSS’ Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Possess knowledge of other procedural documents, e.g. SOPs, etc. that impact PSS.
- Assist in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate.
- Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.
- Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided.
- Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed.
- Build and maintain good PSS relationships across functional units.
- Demonstrate role-specific Competencies on a consistent basis.
- Demonstrate company Values on a consistent basis.
- Begin to prepare Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans under supervision.
- Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project.
- Assist PSS management to identify out of scope work.
- Actively participates in project team and client meetings and liaise with clients, where appropriate.
- Prepare and/or participate in client or regulatory audits.
- Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
- Assist with the set-up of, and the provision of data to Safety Committees/DSMBs.
- Assist in the co-ordination of endpoint committees, as required.
- Any other duties as assigned by management.


- Non-degree + 5 yrs safety experience*
- Associate degree + 4 yrs safety experience*
- Associate degree RN + 4 yrs safety experience*
- BS/BA + 3 yrs safety experience*
- MS/MA + 2 yrs relevant experience** (1-2 yrs safety experience)
- PharmD + 1 yrs relevant experience** (1 yr safety experience)
For PharmD, a one year residency of fellowship can be considered 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.


- Good verbal, written and presentation skills in Japanese and English
- Good communication.
- Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
- High degree of accuracy with attention to detail.
- Functions as a team player.
- Ability to present and share useful business information across departments and functions.
- Ability to anticipate and identify problems and take appropriate action to correct.
- Knowledge of medical and drug terminology
- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
- Knowledge of ICH Guidelines
- Knowledge of Medical Device reporting desirable
- Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
- Good knowledge and understanding of industry and R&D processes and objectives.
- Ability to work independently with minimal supervision
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.


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