Responsible for the line-management of individuals within a team as well as a project team.
Manage direct reports to ensure staff training records are up to date.
- Manage direct reports to ensure staff training records are up to date.
- Responsible for managing performance reviews and issues of direct reports.
- May manage individuals across multiple teams and will take on responsibility for cross department projects.
- Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.).
- May lead or assist with the management of PSS concerning project allocation and resourcing.
- General oversight for the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but not limited to:
- Entry of safety data onto adverse event 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 cases receive appropriate medical review
- prepare follow-up correspondence consulting with 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
- General oversight for the management and processing of expeditable safety reports (ESRs). This includes, but is not limited to:
- review and update adverse event databases and tracking systems
- review of adverse events for completeness, accuracy and appropriateness for ESR
- review of patient narratives
- review the coding of adverse events
- review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
- Complete triage, distribution checklist and quality review of all ESR for assigned projects.
- 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 awareness of Covance's safety database conventions and system functionality.
- Maintain awareness of other client safety database conventions and functionality.
- May prepare, but definitely provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting.
- Responsible for the timely preparation and review of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
- Provide oversight and management of EudraVigilance activities for assigned projects.
- Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.
- Contribute to the generation and review of Time and Cost Estimates for PSS business.
- Work closely with the clinical operations and project management groups to ensure all drug safety activities are performed according to the regulatory and contractual requirements.
- Support the appropriate Clinical Data Management (CDM) team(s) in the reconciliation of SAEs across safety and trials databases.
- Contributes to the development and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms.
- Consistently responsible for assisting with the set-up of, and the provision of data to, Safety Committees / Drug Safety Monitoring Boards.
- Assist in the co-ordination of endpoint committees.
- Participate and demonstrate leadership on projects which enhance team and/or division performance. This includes acting as lead contact for projects including global projects ensuring communication and processes are harmonized.
- Prepare and participate in audits, either by the client or a regulatory agency.
- Consistently contributes to solving technical and/or operational problems of program/project members.
- Consistently proposes and executes innovative solutions which influence program/project direction.
- Generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
- Effectively draft/modify and deliver safety presentations:
- Serious Adverse Event reporting at investigator meetings.
- Client capabilities meetings, as appropriate
- “Department Overview” to internal clients
- Attend client meetings and liaise with clients where appropriate.
- Ensure compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
- Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.
- Participate in Covance project teams and provide training about adverse event reporting to non-PSS personnel.
- Train new employees overall in pharamcovigilance and regulatory reporting.
- Maintains a comprehensive understanding of Covance PSS' SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Possess knowledge of all other CDS procedural documents that impact PSS.
- Maintenance of files regarding adverse event reporting requirements in assigned countries.
- Assist with the generation and review of SOPs, Work Instructions etc.
- Responsible for SOP implementation within assigned team.
- Assist in developing Operational metrics measuring PSS' overall performance.
- Assist with the recruitment of new staff to PSS.
- Build and maintain good PSS relationships across functional units.
- Demonstrate role specific Competencies on consistent basis.
- Demonstrate company Values on consistent basis.
- Financial authority as it relates to projects.
- Any other duties as assigned by management.
- At least 2 years line management and/or project management experience.
- Industry experience of which 4 years is relevant to pharmacovigilance/drug safety knowledge.
- Excellent verbal, written and presentation skills in English and Japanese
- Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
- Work collaboratively with PSS Management's team
- Leadership capabilities
- Good Communication
- High degree of accuracy with attention to detail.
- Ensure client and global regulatory compliance.
- Will present and share useful business information across departments and functions
- Anticipate/identify problems and takes appropriate action to correct.
- Knowledge of medical and drug terminology
- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
- Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products
- Knowledge of Medical Device Reporting desirable
- Knowledge of aggregate reporting desirable
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
- Financially intuitive
- Knowledge of ICH guidelines.
- Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
Level of education required (or experience level which may be substituted for level of education).
Professional designations/certifications/licenses required
- Non-degree + 6-7 yrs safety experience*
- Associate degree + 5-6 yrs safety experience*
- Associate degree RN + 5-6 yrs safety experience*
- BS/BA + 4-5 yrs safety experience*
- MS/MA + 3-4 yrs relevant experience** (2-3 yrs safety experience)
- PharmD + 2-3 yrs relevant experience** (1-2 yrs 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.
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