Head of Drug Safety

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MAIN FOCUS AND MISSION:

Mainly responsible for:

• The Local Pharmacovigilance Responsible Person (LPV) is responsibility for Japan
• The LPV ensures that collection, reporting and handling of safety information associated with Servier products is organized and performed according to global Servier and local regulatory requirements.
• he LPV maintains oversight of safety risk management and all other pharmacovigilance activities and ensures pharmacovigilance compliance and inspection readiness across all affiliate functions.

ROLE & RESPONSIBILITIES:

Responsible for ensuring at the minimum the following activities/tasks:

1. Local Pharmacovigilance system set up

• Coordinate and organize, at the national/area level and in liaison with the Global Safety (GS), all activities in relation with the oversight on the safety profile of the portfolio.
• Create, implement, monitor, and revise as necessary local procedures to ensure the integrity of the pharmacovigilance system.

2.  Local Qualified Person for Pharmacovigilance (QPPV)

• Act as local QPPV for local competent authority.
• Attend MAH meetings of the three Supervisors and report on the progress of safety management activities.

3. Management (includes collection, assessment, follow-up, and submission to PMDA) of Pharmacovigilance (PV) Cases whatever the sources as per internal procedures.

3. Literature surveillance

• Ensure literature screening in local scientific journals and performs case processing for identified safety information as per internal procedure.

3. Report of safety measure taken in foreign countries and research report

• Submit report of safety measure taken in foreign countries and research report to PMDA in accordance with local regulations.

3. Management of key interfaces

• Ensure the oversight and periodic reconciliation on interfaces which are a potential source of PV cases.

3. Study and Program Oversight

• Ensure appropriate safety reporting processes are in place at affiliate level and, if applicable, described in relevant local documents, for global and local clinical trials and post authorization studies in accordance with Global processes and local regulatory authority requirements.
• Provide safety information to ICTR-Japan in order to declare them to investigators, heads of study centers and IRBs in accordance with Japanese regulations.

3. Management of Aggregate Reports

• Provide safety related information to Global teams for the preparation of Aggregate Reports, when necessary.
• Ensure the writing of local format Aggregate Reports, when applicable, in collaboration with Global Safety Periodic Report Unit.
• Ensure maintenance of Aggregate Report tracking table with evidence of submission and compliance metrics.
• Ensure submission of Aggregate Reports to PMDA in accordance with global processes and local regulatory authority’s requirements.

3. Oversight of Risk Management Plan (RMP) and additional Risk Minimization Measures (RMM) Implementation

• Ensures preparation of RMP, oversight of RMP implementation in collaboration with relevant staff and assessment of RMP in accordance with GS and local regulatory authority requirements.
• Ensures the follow-up of the additional RMM distribution locally and its compliance metrics.

3. Signal Detection

• Ensure oversight of the signal evaluation report posted in WRA Portal from Global Safety.

3. Safety Communication and responses to PMDA requests

• Ensure that safety queries, other significant safety issues are performed according to Global processes and local regulatory authority’s requirements.
• Maintain oversight of any safety communication to Healthcare Professionals or consumers as applicable.
• Provide EEA-QPPV office with all relevant information to allow their oversight and follow up on requests from the EEA-QPPV office as applicable.
• Keep up to date with local regulations.

3. Labelling and Commitments

• Ensure awareness and contributes to local safety label updates in collaboration with Local Regulatory Affairs as applicable.
• Contribute to the implementation of commitments, when applicable.

3. Pharmacovigilance Quality System

• Ensure the implementation and maintenance of a local Pharmacovigilance Quality System in accordance with Global processes and local regulatory authority’s requirements.
• Assume responsibility for educating and training relevant personnel in the affiliate and also Business Partners or Service Providers, when applicable, and maintains local training compliance metrics.

14. Local Pharmacovigilance Agreement

• Participate to the negotiation and writing of local pharmacovigilance agreement with local partners or services providers.
• Inform the Global Safety International Unit before hands on all contracts that are set up locally regarding pharmacovigilance activities and/or which have an impact on pharmacovigilance activities (any contract with a partner company for subcontracting of specific pharmacovigilance activities).
• Ensure compliance with agreements.
• On a timely manner, provides feedback to the Global Safety International Unit on all changes the LPV is aware of (e.g.: change in products concerned by the pharmacovigilance agreement).

15. Business continuity

• Ensure continuity of pharmacovigilance activities at the local level, including the set- up of a system to cover out of business hours.
• Maintain a safety database for continuous electronic safety reporting in collaboration with GS and DDIS.

15. Regulatory Intelligence

• Ensure continuous screening for updates of the local legislation, perform the impact analysis and inform Global Safety of any change.

15. Archiving

• Ensure that PV documents are archived in accordance with local regulatory requirements and data protection rules, as applicable.

15. Audit and Inspection

• Inform the Global Safety as soon as a notification of an PV audit by a Business Partner or PV inspection is received and ensures the local contact point.
• Ensure the CAPA plan implementation within the defined timelines.

15. Self-inspection

• Conduct a self-inspection at least once a year.

20. Management of the local pharmacovigilance unit (staff and activities)

• Lead a team of motivated individuals and promotes pharmacovigilance standards across the organization.
• Ensure pharmacovigilance activities are properly resourced.
• Set up team meetings for staff to communicate closely with each other.

YOUR PROFILE:

• Qualification:

Scientific degree (physician, pharmacist, biologist, master degree in science)

• Experience

At least 3 years of experience in pharmacovigilance

• Language

Fluency in English

Fluency in Japanese

• IT aptitude

Good IT experience: pack office and internal tool

• Leadership Model aptitude

Manager of a PV team PV

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.