Benefit Risk & Therapeutic Area Specialist, MEA

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  . Follow @abbvie on  Twitter ,  Facebook ,  Instagram ,  YouTube and  LinkedIn . 

Job Description

This role performs product-specific benefit-risk activities and support in overseeing the safety profile of Abbvie MEA medicinal products in clinical development and those authorized and marketed, including devices and combination products.

Risk Management

• Reviews global risk management plan (RMP) and advises on local impact.
• Collaborates with BR & TA Lead in the preparation of affiliate risk management team (ARMT) Meetings when required. Create local implementation plan (LIP) and ensure timely completion.
• Creates and review local RMP annex for assigned products.
• Submission of Risk Management related documents to regulatory authority.
• Tracks Risk Minimization Tool distribution and measures effectiveness when required.
• Implementation of relevant LIP and accompanying additional risk minimization tools (RMz), when and where applicable.

Periodic Safety Reporting and Development Safety Reporting

• Reviews periodic safety update reports (PSUR)/ drug safety update reports (DSUR) /Line listings and advise on local impact.
• Prepares local PSUR annex when applicable.
• Prepares cover letter and submits it to Regulatory authority/Ethics Committees or Investigators when applicable.
• Advises functional lead on aggregate report schedule updates.

Product Safety Monitoring & Therapeutic Area

• Develops a relevant knowledge of the therapeutic area (TA) - disease knowledge, product knowledge, safety profile, the benefit risk information, and the therapeutic landscape.
• Submission of significant safety issues to local regulatory agency.
• Reviews of safety data collection requirements for research activities (i.e., investigator-initiated studies (IIS), non-interventional studies (NIS), collaborative studies etc.) when applicable.
• Builds strong partnerships and works collaboratively with stakeholders and other functions across the business, such as Regulatory Affairs, Medical Affairs, Brand Teams, as applicable.
• Performs surveillance of Local Safety Information and communicates to affiliate medical director (AMD) and pharmacovigilance & patient safety (PPS) for escalation and evaluation. 
• Oversights & internal communication of product safety updates, local safety data trending and monitoring activities.

N-QPPV role responsibilities

• QPPV oversees MAH's PV system, ensuring 24/7 availability for competent authorities.
• Responsibilities include oversight of the PV system, quality system/SOPs, compliance, adverse event processing, safety data reconciliation, organized data collection programs, safety data exchange agreements, training, audits, risk management, safety monitoring, and after-hours availability.
• QPPV has an overview of product safety profiles, emerging concerns, and adherence to marketing authorization conditions.
• Awareness of risk minimization measures, content of applicable risk management plans, and post-authorization safety studies.
• Ensures pharmacovigilance and submission of all related documents in line with legal requirements and regulatory guidance.
• Provides input for regulatory actions and responds promptly to competent authority requests.
• Acts as a subject matter expert on local PV regulations and policy, ensuring local PV regulatory obligations are met.
• Monitors competent authority homepages/websites and informs PPS of any impact on AbbVie products.
• Delegates tasks under supervision, maintaining system oversight and safety profile awareness with documented delegation.

Qualifications

• UAE National with Family Book
• Medical, pharmacy or life-sciences degree (or equivalent).
• At least four years’ experience working in the pharmaceutical industry in a multi-country pharmacovigilance.
• Ability to identify, analyze, and translate specific territory and corporate needs in order to support both internal and external customers and achieve business and clinical objectives.

Essential Skills, Experience, and Competencies

• Fluency in written and oral English is essential to facilitate communications with relevant stakeholders. French is preferable.
• Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency.
• The QPPV must possess adequate theoretical knowledge and practical experience in PV activities and systems or delegate to appropriately qualified individuals. They should have a comprehensive understanding of regulatory and PV monitoring requirements for their assigned territories, adhering to any specific training mandated by competent authorities as per local regulations.

Additional Information

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.