Affiliate Safety Representative

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

PRIMARY FUNCTION:

Responsible to ensure that all aspects of Pharmacovigilance at the affiliate level meets AbbVie’s statutory and ethical responsibilities, and complies with local and regional PV regulations, for the applicable product portfolio.

Acts as the Affiliate’s lead for pharmacovigilance matters with the National Regulatory Agency and AbbVie PSEQ (Pharmacovigilance and Patient Safety, Epidemiology and Research & Development Quality Assurance) function.

Serves as the local Qualified Person for Pharmacovigilance (QPPV) , with sufficient authority to influence the performance of the quality system and pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements .

RESPONSIBILITIES:

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 Regional PV Teams and/or outsourced partners.
• 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.
• Delegates specific tasks under supervision and with documentation, to appropriately qualified and trained individuals, provided that the QPPV maintains system oversight and overview of the safety profiles of all products.

Quality Management System

Partners with PSEQ 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, translating and reconciling adverse events and other safety information reportable to PPS from spontaneous and solicited sources and from clinical studies.
• Partners with Regional PV Teams in PSEQ to ensure reporting of both clinical and post-marketing
• Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agency,
• Ethics Committees and Investigators, to comply with corporate PV procedures and with local and regional PV regulations as required.

Audits and Inspections

• 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
• Regional PV Teams are set-up and structured, supporfing the fulfilment of local legal requirements.
•  Collaborates with PSEQ Regional teams in managing audits of processes executed by the PSEQ Regional PV Teams and audits of affiliate service providers/third parties.
• Supports PSEQ Regional teams 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

• Acts as key safety advisor for affiliate cross-functional partners on safety topics to address business needs and ensure 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 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.
  • Content of local SDEAs and other PV agreements conforms to AbbVie procedures and local requirements and maintains the inventory in the PPS PV Agreements Database
  • Compliance with local agreements.

PV Training

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

Risk Management

•  Leads the Affiliate Risk Management Team (ARMT) with the AMD.
• Coordinates the receipt and distribution of RMP, Core Implementation Plan (CIP) and additional risk minimization measures (aRMM) to 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 and where applicable, seek involvement of relevant PSEQ stakeholders during development or revision of the COUNTRY Specific Annex (if applicable), Local Implementation Plan (LIP) & local aRMM.
• Performs the assessment and implementation of the CIP and accompanying aRMM, when applicable

Safety Monitoring

• Maintains an overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and 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.
• Understands and monitors incoming local safety data and communicate changes or potential concerns to the PSEQ Product Safety Team Lead and the EU QPPV (for products marketed in the EEA), for evaluation.
• Reviews summary reports of local research-related acidifies and communicate any safety insights/findings with Medical Teams and PSEQ.
• 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 & PV strategy incorporating proactive PV contributions to ensure a successful product / indication launch at the affiliate.

PV Advocacy

• Maintains awareness, oversight and actively contributes to assessing the impact of new legislations on the PV system and drives Abbvie PV advocacy efforts via strong internal & external collaboration and engagement in local trade associations, industry network, and with Regulatory Agencies.
• Collaborates on internal and external PV advocacy efforts, in alignment with the AbbVie, PSEQ, 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.
• 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.

AUTHORITY AND REPORTING LINES:

• This position reports into the Affiliate Medical Director.

INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS:

• Affiliate medical, regulatory affairs, clinical, quality assurance and customer service personnel.
• Affiliate Marketing, Sales and Operations personnel to ensure that all employees are trained and understand their responsibilities for reporting of any safety information.
• National Regulatory Agency responsible for product safety.
• Pharmacovigilance and Patient Safety, Epidemiology and Research & Development Quality Assurance (PSEQ), including but not limited to Regional PV Lead, Area PV Head, Area PV Product Lead, QPPV Office and Risk Management Teams.
• Healthcare Practitioners, consumers and patients.

IDEAL CANDIDATE:

• Medical, pharmacy or life-sciences degree (or equivalent).
• At least two years’ experience working in the pharmaceufical industry in a pharmacovigilance role is
• required.
• Excellent wriften and spoken communicafion and presentafion skills.
• Fluency in wriften and oral English is essenfial to facilitate communicafions with PSEQ, Area/Regional
• Medical and other headquarters funcfions.
• 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.
• Sound judgment, strong planning and organizational skills, and the ability to get things done.
• Demonstrated strong sense of urgency.

Crifical Success Factors:

•  Builds and maintains strong relationships with affiliate stakeholders (e.g. Medical Affairs, Regulatory Affairs, Commercial) and PSEQ.
• 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.
• * National QPPV items may need to be replicated into the JD for regional PV team members that are assigned as N-QPPV back-up.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.