AbbVie

Global biopharmaceutical company developing medicines

PV Lead

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeShanghai, ChinaNo salary listedHybrid

About the Job

Requirements

A medical, pharmacy, or life-sciences degree, or equivalent, is required.
At least two years of experience working in the pharmaceutical industry in a pharmacovigilance role is required.
For National QPPV positions, adequate theoretical knowledge and practical experience of pharmacovigilance activities and the system under purview, a sound understanding of applicable regulatory and pharmacovigilance monitoring requirements, and any training required by relevant regulatory agencies are required.
Fluency in written and spoken English is essential for communication with PSEQ GPS, Area/Regional Medical, and other headquarters functions.
Fluency in written and spoken local language is required for communication within the affiliate medical department and with the National Regulatory Agency.
Strong commitment to compliance with relevant rules and procedures, scientific quality, and integrity is required.
The role requires the ability to understand and apply scientific concepts effectively.
Sound judgment, planning and organizational skills, and the ability to execute work are required.

Responsibilities

Ensure pharmacovigilance processes, procedures, and systems comply with AbbVie global procedures and local or regional regulations.
Maintain oversight of activities fulfilling local and applicable regional pharmacovigilance regulations, including work by PSEQ, Regional PV Teams, and outsourced partners, in collaboration with Regional PV Leaders responsible for day-to-day operational activities.
For National QPPV or back-up National QPPV positions, oversee the Pharmacovigilance System Master File and ensure it accurately reflects the current pharmacovigilance system.
Partner with PSEQ and Regional PV Teams to ensure affiliate procedures align with corporate procedures and comply with local and regional regulations.
Manage non-conformities and planned departures from corporate or local procedures under the global issue and exception management process, and ensure corrective and preventive actions are completed on schedule.
Oversee the pharmacovigilance training plan and ensure local and affiliate personnel comply with corporate and local training requirements; oversee partner-company staff training compliance according to contract requirements.
Ensure processes are in place for intake, processing, follow-up, translation, and reconciliation of adverse events and other reportable safety information from spontaneous, solicited, and clinical-study sources.
Partner with PSEQ GPS Regional PV Teams to ensure clinical and post-marketing Individual Case Safety Reports and periodic and aggregate reports are submitted to regulatory agencies, ethics committees, and investigators in accordance with applicable procedures and regulations.
Serve as affiliate lead and point of contact for affiliate pharmacovigilance audits and regulatory-authority inspections, demonstrating understanding of the AbbVie pharmacovigilance system and supporting local legal requirements.
Collaborate with GPS PSEQ Regional PV Teams to manage audits of regional-team processes and affiliate service providers and third parties.
Collaborate with GPS Regional PV Teams on corrective and preventive actions in response to observations and track actions through timely completion.
Advise affiliate cross-functional partners on safety topics and assess business partnerships that may identify or handle safety information for applicable pharmacovigilance requirements; ensure relevant safety data exchange agreements are implemented.
Work with PSEQ GPS Regional PV Teams to identify local sources of adverse events and other safety information and establish mechanisms for collection and collation of data by PSEQ GPS.
Ensure local Safety Data Exchange Agreements and other pharmacovigilance agreements conform to AbbVie procedures and local requirements, maintain the agreement inventory in the PPS GPS database, and ensure compliance with local agreements.
Collaborate with PSEQ GPS Regional PV Teams to maintain overall training compliance, the pharmacovigilance training matrix, and additional training materials as required.
Collaborate with PSEQ GPS Regional PV Teams to monitor local and applicable regional pharmacovigilance intelligence and lead impact assessments.
Lead affiliate risk-management activities with the Affiliate Medical Director in alignment with local regulations.
Coordinate receipt and distribution of Risk Management Plans, Core Implementation Plan Strategy, and additional risk-minimization measures to relevant affiliate stakeholders and risk-management team members.
Develop detailed knowledge of Risk Management Plans and product risk-benefit profiles.
Liaise with affiliate stakeholders, the Office of Risk Management, and relevant global stakeholders on local or country-specific Risk Management Plans, annexes, implementation plans, and additional risk-minimization measures.
Assess and implement the Core Implementation Plan and associated additional risk-minimization measures when applicable.
Monitor medicinal-product safety profiles and emerging safety concerns in the jurisdiction, including authorization conditions, safety commitments, safe-use obligations, and post-authorization safety studies requested by regulatory agencies.
Drive generation and interpretation of safety evidence across the product lifecycle.
Monitor incoming local safety data and communicate changes or potential concerns to the PSEQ GPS Product Safety Team Lead and, for products marketed in the EEA, the EU QPPV.
Oversee pharmacovigilance processes and actively monitor safety data to generate evidence informing risk management, regulatory submissions, and product safety profiles.
Review summary reports of local research activities and communicate safety insights and findings to Medical Teams and PSEQ GPS.
Lead product-safety communication and education initiatives for local cross-functional teams on major pharmacovigilance topics and local data sources.
Set local safety and pharmacovigilance strategy, incorporating proactive pharmacovigilance contributions to support successful product or indication launches at the affiliate.
Maintain awareness of and contribute to assessing the impact of new legislation on the pharmacovigilance system; drive advocacy through internal and external collaboration with trade associations, industry networks, and regulatory agencies, aligned with AbbVie, PSEQ GPS, and QPPV Office guidance.
Ensure a local affiliate pharmacovigilance disaster-recovery and business-continuity plan is established to continue critical processes on a risk-based basis.
For National QPPV or back-up National QPPV positions, remain continuously available to AbbVie on a 24-hour basis when applicable, establish an after-hours adverse-event reporting process, and ensure a disaster-recovery and business-continuity plan supports critical pharmacovigilance processes.

Desired Qualifications

Build and maintain strong relationships with affiliate stakeholders, including Medical Affairs, Regulatory Affairs, and Commercial, and with PSEQ GPS.
Learn quickly, grasp essential issues, manage complexity and change, and adjust course when needed to add value to the pharmacovigilance system.
Act consistently with AbbVie ethics, obligations, and local laws, prioritizing patient safety, partnerships, and AbbVie’s overall interests.
Strengthen use of product-safety knowledge and communicate scientific safety evidence and benefit-risk information to area and affiliate stakeholders to inform business strategies.
Demonstrate strong customer orientation, planning, organizational skills, and a sense of urgency.
Demonstrate excellent written and spoken communication and presentation skills.

Job Description

Oversight of the Pharmacovigilance System

Ensures that PV processes, procedures and systems are in place to comply with AbbVie Global PV procedures and with local and/or regional PV regulations.
Maintains oversight of the performance of all activities that fulfil local and applicable regional PV regulations, including those performed by PSEQ the Regional PV Teams and/or outsourced partners, in collaboration with Regional PV Leaders who oversee day-to-day operational PV activities.
(National QPPV / back-up National QPPV only) Maintains oversight of AbbVie’s PV System Master File (PSMF) with the authority to ensure that the information contained is an accurate and up-to-date reflection of the PV system.

Quality Management System

Partners with PSEQ the Regional PV Teams to:

Ensure Affiliate PV System procedure(s) aligns with corporate PV procedures and complies with local and regional PV regulations.
Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule.
Maintain oversight of the PV training plan and ensure training compliance of local PV personnel and other affiliate personnel with corporate and local PV training requirements.
Oversee training compliance of partner company staff according to local contract requirements.

Adverse Event & Periodic Safety Reporting

Maintains oversight of the PV system and ensures that processes, procedures and systems are in place for intake, processing, conducting follow up, translation and reconciliation of adverse events and other safety information reportable to PPS GPS from spontaneous and solicited sources as well as from clinical studies.
Partners with the Regional PV Teams in PSEQ GPS to ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agencies, Ethics Committees and Investigators, in compliance with corporate PV procedures and with local and regional PV regulations as required.

Audits and Inspections

Serves as the Affiliate Lead and point of contact for affiliate PV audits and Regulatory Authority PV inspections, demonstrating understanding of the overall AbbVie PV system and how Global PV processes and PSEQ the GPS Regional PV Teams are set-up and structured, supporting the fulfilment of local legal requirements.
Collaborates with the GPS PSEQ Regional PV Teams in to manage managing audits of processes executed by the Regional PV Teams and as well as audits of affiliate service providers and third parties.
Supports PSEQ Collaborates with GPS Regional PV Teams in the development of CAPA in response to observations and the tracksing actions to completion in a timely manner.

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

Acts as key safety advisor for affiliate cross-functional partners on safety topics to address business needs and ensure ensuring that business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements, and that applicable PV and safety data exchange agreements are implemented.
Partners with PSEQ the GPS Regional PV Teams to ensure that:

All sources of adverse events and other safety information are identified at the local level and mechanisms are in place for collection and collation of all data by PSEQ GPS.
Content of local Safety Data Exchange Agreements (SDEAs) and other PV agreements conforms to AbbVie procedures and local requirements and maintains the inventory in the PPS GPS PV Agreements Database.
Compliance with local agreements.

PV Training

Collaborates with PSEQ the GPS Regional PV Teams to ensure 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.

Legislation Intelligence

Collaborates with PSEQ the GPS Regional PV Teams to ensure monitoring of local (and applicable regional/area) PV-relevant hard intelligence, and leads leading the impact assessment of such intelligence them.

Risk Management

Leads the Affiliate Risk Management Team (ARMT) local risk management activities in alignment with local regulations with the Affiliate Medical Director (AMD).
Coordinates the receipt and distribution of Risk Management Plans (RMPs), Core Implementation Plan Strategy (CIS CIP) and additional risk minimization measures (aRMM) to relevant affiliate stakeholders ARMT members.
Develops a deep knowledge of the Risk Management Plans (RMPs) to obtain information on the risk/benefit profile of products.
Liaises with ARMT & Benefit Risk Management (BRM) Team the affiliate stakeholders and the Office of Risk Management and where applicable, seek involvement of relevant PSEQ global stakeholders during the development or revision of the local RMP or RMP COUNTRY Specific Annex (if applicable), Local Implementation Plan (LIP) & local or country-specific aRMM.
Performs the assessment and implementation of the CIS and accompanying aRMM, when applicable.

Safety Monitoring and Evidence Generation

Maintains an overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and maintains awareness of conditions or obligations adopted as part of the marketing authorizations, commitments relating to safety or the safe use of the products and of post-authorization safety studies requested by a regulatory agency.
Be a key driver in the generation and interpretation of safety evidence across the product lifecycle.
Understands and monitors incoming local safety data and communicate changes or potential concerns to the PSEQ GPS Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation.
Through the oversight of pharmacovigilance processes and the active monitoring of safety data, the ASR ensures that robust evidence is generated to inform risk management, regulatory submissions, and product safety profiles.
Reviews summary reports of local research-related activities and communicates any safety insights/findings with Medical Teams and PSEQ GPS.
Leads product safety communication and education initiatives for local cross-functional teams on major PV topics and on local data sources.

Launch Readiness

Sets a solid local safety and PV strategy incorporating proactive PV contributions to ensure a successful product or indication launch at the affiliate.
Acts as key safety advisor for affiliate cross-functional partners on safety topics.

PV Advocacy

Maintains awareness, oversight and actively contributes to assessing the impact of new legislations on the PV system. Drives AbbVie PV advocacy efforts through strong internal and external collaboration including and engagement with in local trade associations, industry network, and with Regulatory Agencies.
Collaborates on internal and external PV advocacy efforts, in alignment with the AbbVie, PSEQ GPS, and QPPV Office advocacy guidance.

After Hours Availability & Business Continuity

Ensures that a local Affiliate PV Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV.
(National QPPV / back-up National QPPV only) 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.

Qualifications

• Medical, pharmacy or life-sciences degree (or equivalent).
• (National QPPV only) (adjust above accordingly to reﬂect the regulatory requirements for NQPPV
qualiﬁcations)
• At least two years’ experience working in the pharmaceutical industry in a pharmacovigilance role is
required.
• (National QPPV only) Adequate theoretical knowledge and practical experience of PV activities and
system under purview (as stipulated in local guidance) and sound understanding of the regulatory and PV
monitoring requirements for assigned territory(ies) that comply with any speciﬁc training requirements
mandated by relevant regulatory agencies.
• Excellent written and spoken communication and presentation skills.
• Fluency in written and oral English is essential to facilitate communications with PSEQGPS, Area/Regional
Medical and other headquarters functions.
• Fluency in written and oral local language is a requirement to facilitate communications within the aﬃliate
medical department, and with the National Regulatory Agency.
• High customer orientation.
• Strong commitment to compliance with the relevant rules and procedures, and to scientiﬁc quality and
integrity.
• Demonstrates strong scientiﬁc acumen and the ability to understand and apply scientiﬁc concepts
eﬀectively.
• Sound judgment, strong planning and organizational skills, and the ability to get things done.
Demonstrated strong sense of urgency

CRITICAL SUCCESS FACTORS:
• Builds and maintains strong relationships with aﬃliate stakeholders (e.g. Medical Aﬀairs, Regulatory Aﬀairs,
Commercial) and PSEQGPS.
• Learns fast, grasps the “essence”, ability to manage complexity and changes to change course quickly where
indicated to add value to the PV system.
• Acts consistently with AbbVie’ s ethics, obligations and local laws – putting patient safety, partnerships and
overall AbbVie’s interests before individual, immediate team and functional interests.
• Strengthens the use of product safety knowledge and channels scientiﬁc safety evidence and beneﬁt-risk
information to area and aﬃliate stakeholders to positively impact business strategies.

Additional Information

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

AbbVie

PV Lead

About the Job

Requirements

Responsibilities

Desired Qualifications

Job Description

Qualifications

Additional Information

About the Company

AbbVie

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