Pharmacovigilance Therapeutic Area Specialist


About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries.
For more information, please visit www.abbvie.com.
Summary of Job Description: The Pharmacovigilance (PV) Therapeutic Area (TA) Specialist works collaborative with the ASR, PV Operations Manager, PV Compliance Manager and Benefit Risk Manager to perform Product Safety Monitoring activities and to ensure that the affiliate complies with local, global, and regulatory requirements and with Good PV Practices in Organized Data Collection (ODC) programs run by the affiliate. This includes performing the following activities within the assigned PV Therapeutic Area, ODC assessment reviews, vendor management, vendor quality assessments, vendor PV agreements and training of vendors and Abbvie associates in ODC responsibilities. The PV TA Specialist works closely with Medical Affairs and TA Brand Teams, supporting the design and execution of medical and commercial strategic initiatives.
Major Responsibilities: Therapeutic Area

  • Develop a deep knowledge of the Therapeutic Area - disease knowledge, product knowledge, the safety profile, the benefit risk information, and the competitor landscape
  • Effectively communicate safety information to stakeholders to positively impact business strategies such as launch excellence; patient experience; emerging safety information
  • Detect opportunities that add value to the business
  • Build strong partnerships and work collaboratively with stakeholders and other functions across the business
Pharmacovigilance System
  • Support the PV management in fulfilling the responsibility for the coordination and execution of all aspects of PV (drug safety) to ensure that all of AbbVie’s statutory and ethical responsibilities are met in the area of ODC, Vendor and Contract Management and Product Safety Monitoring.
Quality System
  • Support the development and maintenance of local procedures that relate to ODC, Vendor and Contract Management and Product Safety Monitoring activities that are in line with global requirements and ANZ legislation.
  • Support the local PV Exception Reporting/CAPA process.
Audit and Inspection Management
  • Support as required internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections
  • Support the development of CAPA in response to observations and completion of corrective/preventative actions in a timely manner.
Organised Data Collection (ODC) Activities
  • Act a Subject Matter Expert on safety obligations within ODC programs, and provide guidance to local interacting departments, vendor companies, PPS and AVE as required.
  • Liaise in a matrix environment with PV, Medical, QA, Customer Relations, Patient Engagement, Business Intelligence and the Commercial Business Units
  • Assess various affiliate projects for ODC program requirements and for impact to adverse event (AE) and quality complaint (QC) generation.
  • Prepare, implement, and maintain PV Agreements with service providers.
  • Ensure new vendors are qualified to perform AE/QC reporting prior to implementation of PV Agreements or prior to patient/HCP interactions on behalf of AbbVie.
  • Roll out the PV vendor training program including initial and annual refresher training. Ensure that any training of vendor team\s are completed according to PV Agreement requirements and are appropriately documented. In addition, ensure PV training of PSP personnel involved in AbbVie-run PSPs is undertaken.
  • Document any new programs or any significant changes in existing programs in the global PSP and MRP Inventories.
  • Perform ongoing vendor compliance monitoring and collaborate with service providers in continuous improvement projects. Escalate non-compliance issues to PV management.
  • Submit new and updated PV Agreements to PPS as per procedure.
Product Safety Monitoring
  • Maintain awareness of and input into safety-related product enquiries/issues received from external stakeholders/vendors, working with Medical Affairs, Regulatory Affairs, and the Product Safety Team (PST) as required.
  • Involve internal affiliate stakeholders with respect to the results of product safety monitoring.
  • Monitor incoming safety information and communicate changes or concerns to the PV Management for escalation and evaluation.
Benefit Risk Management
  • Support the Benefit Risk Manager with AbbVie Risk Management Team (ARMT) meetings.
  • Support the Benefit Risk Manager with the management of additional risk minimisation activities, such as review, approval, and distribution activities
  • Support the Benefit Risk Manager with the generation and management of the Australian Specific Annex for relevant products.
  • Review summarize TA specific PSURs and communicate as appropriate.
  • Support the Benefit Risk Manager with managing relevant SSI as required.
  • When required act as back-up for the Benefit Risk Manager with respect to risk management, PSUR, legislation intelligence and SSI
PV Agreements and Contracts
  • Actively support the PV Operations Manager, with developing and maintaining PVrelated agreements and contracts with vendor companies.
  • Working with PPS to ensure agreements conform to global standards.
  • Maintain the inventory of PV-related agreements and contracts
PV Advocacy
  • Support AbbVie PV priority topics and business priorities to influence the external environment and maximize external engagement, working with other AbbVie local and global advocacy partners
  • Support internal PV advocacy efforts to elevate PV understanding across the Affiliate
Other Responsibilities
  • Completes other activities or projects that support the overall performance of the affiliate PV.
  • Comply with global and local PV training requirements in ISOTrain and other mandatory training as required by PPS.
  • When required act as back-up for the PV ICSR and Quality Manager with respect to ICSR Management, PV Training,

Qualifications
Education/Experience Required:
  • Medical, pharmacy or life-sciences degree (or equivalent)
  • Senior Associate level several years in Pharma industry
  • Experience/good understanding across the entire PV system
  • Experience working in the pharmaceutical industry in a Pharmacovigilance, Clinical Development, Medical Affairs or Regulatory Affairs role.
  • Good understanding of medical concepts
  • Experience in conducting training
  • Demonstrated understanding of Australian and New Zealand Pharmacovigilance and related regulations
  • Knowledge of understanding and interrogating safety data
  • Good understanding of healthcare environment and regulatory framework for AU and NZ
  • Management of Benefit Risk activities
Essential Skills & Abilities:
  • Demonstrate strategic thinking, understand business priorities and Integrated Brand Plan strategy. Identifying the connection of how PV can ‘add value’
  • Resilience despite obstacles, uncertainty, and ambiguity
  • Have a global mindset: cultivate cross-cultural, cross-geographical collaboration
  • A passion for PV Excellence and Patient Safety
  • Engagement through internal partnerships and external presence
  • Work cross functionally and foster strong partnerships
  • Ability to communicate information accurately
  • Ability to work effectively as a member of the PV team and broader Medical department
  • Focused on compliance; identifies, manages, and escalates issues in a timely manner
  • Demonstrated ability to take the initiative and challenge the status quo
  • Demonstrated attention to detail and prioritization
  • Demonstrated ability to learn fast, grasps the “essence” and can change course quickly as required
  • Excellent written and spoken communication and presentation skills
  • Fluency in written and oral English in order to facilitate communications with PPS, regional
  • Medical, other global functions and Health Authorities
Leadership Attributes: All for One AbbVie Clear and Courageous Decide Smart and Sure Agile and Accountable Make Possibilities Real
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.