Specialist or Senior Specialist, Pharmacovigilance

Purpose:

This position is accountable for executing the day-to-day operations and compliance activities by leading

a team of PV operations to maintain high-functioning PV systems across assigned region remit. Reports

directly to Japan PV Operational Lead.

Responsibilities:

Metrics and Oversight of the Pharmacovigilance System

Supports the provision of metrics that will ensure oversight of all aspects of the performance and

functioning of the PV system in compliance with local regulations and internal company

timelines/standards.

Quality Management System

Develops and maintains local/regional procedures in line with corporate procedures and local

requirements.

Performs the impact assessment of new/updated corporate policies, process, and procedures.

Collaborate with Safety Science, along with Safety Control Manager, actively assists with the PV

Exception Reporting/CAPA process.

Actively assists with the business continuity plan and testing.

ICSR Management

Records, processes, and conducts follow up and translates adverse events and other safety

information from spontaneous and solicited sources.

Performs ICSR expedited reporting according to the local requirements.

Ensures local-language medical or scientific literature review.

Implements an appropriate local quality control (QC) procedure to ensure quality of information

entered and report decisions.

Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with

global procedures.

Periodic Safety Reporting

Partner with Safety Science and any other relevant functions, leads the preparation of periodic

safety reports of assigned TA' products (J-DSUR, J-PSUR, Non-Serious Unexpected ADR Periodic

Safety Report and Re-examination dossier).

Ensures submission of periodic safety reports and ensures documentation of evidence.

Audits and Inspections

Actively assists in managing internal PV audits, audits of affiliate service providers/third parties and

Regulatory Authority PV Inspections.

Actively assists in the development of CAPA in response to observations and the tracking actions to

completion in a timely manner.

Partnership with business partner with possibility for identification and/or handling of safety

information

Ensuring all PV requirements are in place for activities where there is a reasonable possibility for

the identification and/or handling of safety information in accordance with AbbVie procedures and

local requirements.

PV Training

Ensures overall training compliance with corporate procedures and local PV requirements,

including the maintenance of the PV Training Matrix and the development of additional PV training

materials, as required.

Risk Management (if applicable)

Collaboration with Safety Science is essential for the following tasks. Do refer to the DOP and JPN

GL 04, which are defined separately, for more details.

Develops a deep knowledge of the Risk Management Plans (RMPs) to obtain information on the

risk/benefit profile of products, for implementation of EPPV locally.

Liaises with affiliate safety science and where applicable, during development or revision of the

COUNTRY RMP (if applicable)

Safety Monitoring

For EPPV, understands and monitors incoming local safety data and communicate changes or

potential concerns to the affiliate safety science, for evaluation.

Launch Readiness

Collaborate with Safety Science and along with Safety Control Manager to ensure the successful

launch of new drugs/additional indications in Japan by executing a solid local strategy to ensure

local regulatory compliance.

After Hours Availability & Business Continuity

Ensures availability to be at AbbVie’s disposal permanently and continuously on a 24-hour basis, if

applicable, and that an after-hours process is in place for the reporting of AEs and that a Disaster

Recovery Plan/Business Continuity Plan is established to allow for continuation of critical business

processes for PV.

Affiliate Review Process for research

Review the assigned TA and products Reg-PMOS protocols from a safety perspective.

Qualifications:

A minimum of 2 years’ experience required within the pharmacovigilance or a related field.

Effective communicator and able to work effectively in teams and a cross functional environment.

Strong commitment to compliance with relevant rules and procedures.

Effective planning and organizational skills, and the ability to complete activities with high quality

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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