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. Follow us on Summary of Job Description:

The Pharmacovigilance (PV) Therapy Area (TA) Specialist works collaboratively with the Head

of PV \ Affiliate Safety Representative (ASR), PV Operations Manager, PV Compliance

Manager and PV 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 Therapy Area: contract assessment

reviews, vendor management, vendor quality assessments, vendor PV agreements and

training of vendors and Abbvie associates in ODC and other 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:

Therapy Area  Develop a deep knowledge of the Therapy 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

educational strategies and business strategies such as launch excellence; patient

experience; emerging safety information.  Through local safety monitoring, detect opportunities that add value to the

understanding of the use of Abbvie products.  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 ODC, Vendor and Contract Management and Product

Safety Monitoring.

Benefit Risk Management

 Support the PV Benefit Risk Manager with Affiliate Risk Management Team (ARMT)

meetings.

 Support the PV Benefit Risk Manager with the management of additional risk

minimisation activities, such as the review and approval of materials monitoring of

distribution activities and training.

 Support the PV Benefit Risk Manager with the generation and management of the

Australian Specific Annex for relevant products.

 Review and summarize TA specific PSURs and communicate as appropriate.

 Support the PV Benefit Risk Manager with managing relevant safety communications

including Significant Safety Issue (SSI) as required.

 When required act as back-up for the PV Benefit Risk Manager with respect to risk

management, PSUR, regulatory intelligence and SSI.

Clinical trial oversight of medical affairs / IIS studies

 Ensures oversight & management of safety reporting responsibilities in medical affairs

activities including Safety Review Plan and ongoing monitoring

 Review clinical study/medical research protocols and investigator

contracts/agreements to ensure compliance with PV Obligations and document

appropriately.

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.

 When required act as back-up for the PV Compliance Manager with respect to

compliance oversight; quality system management; audits & inspection management;

PV training and ICSR Vendor oversight

Education/Experience Required:

 Medical, pharmacy or life-sciences degree (or equivalent)

 Senior Associate level with several years’ experience in the pharmaceutical 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

Pharmacovigilance Therapy Area Specialist Version 3.0_01 December 2020

 Knowledge of how to understand and interrogate safety data

 Good understanding of healthcare environment and regulatory framework for Australia

and New Zealand

 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