Pharmacovigilance Therapy Area Specialist

5 months ago

Mascot, Australia AbbVie Full time

**Company Description**
**Job Description** The Opportunity**

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 R

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