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Senior Drug Safety Associate

3 months ago

Mascot, Australia AbbVie Full time

Company Description

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

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.

What you'll be doing

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.

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 roll-out and monitoring of mandatory onboarding and annual safety information training to AbbVie employees and contractors.
  • 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 promptly
  • PV Partnership / Organised Data Collection (ODC) ActivitiesActively support the ASR / PV Operations Manager, with developing and maintaining PV-related agreements and contracts with vendor companies and service providers.
  • Working with Pharmacovigilance and Patient Safety (PPS) to ensure agreements conform to global standards.
  • Maintain the inventory of PV-related agreements and contracts
  • Act a Subject Matter Expert on safety obligations within ODC programs, and provide guidance to, internal stakeholders, vendor companies, PPS and International PV as required.
  • Liaise in a matrix environment with PV, Medical, QA, OEC, Legal, Customer Relations, Corporate Communications, Patient Experience, Business Intelligence, and the Commercial Business Units
  • Proactively partner with program owners to provide PV input during the conception, design, and development of programs, and assess various affiliate projects for PV requirements and for impact to adverse event (AE) and product quality complaint (PQC) generation.
  • Prepare, implement, and maintain PV Agreements with service providers.
  • Submit new and updated PV Agreements to PPS as per procedure.
  • Ensure new vendors are qualified to perform AE/PQC 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.
  • Document any new programs or any significant changes in existing programs in the global ODC PV Inventory.
  • Perform ongoing vendor compliance monitoring and collaborate with service providers in continuous improvement projects. Escalate non-compliance issues to PV management.

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 global Product Safety Team\s (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 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
  • to compliance oversight; quality system management; audits & inspection management; PV training and ICSR Vendor oversight

Qualifications

Preferred experience

  • 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
  • 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

Additional Information

Let's create a more inclusive world together

AbbVie is dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We strongly believe that diverse perspectives are essential for achieving exceptional outcomes, and we actively encourage applications from individuals of all ages, nationalities, abilities, and cultures. We are committed to providing equal opportunities for all employees and ensuring a fair and inclusive recruitment process. If you have any specific requests or accessibility requirements, please inform us at the time of application (via ), and we will make the necessary adjustments to accommodate your needs.

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.