AbbVie Pharmacovigilance Associate in Sydney, Australia
Australia, New South Wales, Sydney
Support Head of Pharmacovigilance (PV), PV Team Leader/s and Manager/s to fulfil the responsibility for the execution of all aspects of PV Individual Case Safety Reporting (ICSR) processing to ensure that all of AbbVie’s statutory and ethical responsibilities are met.
Adverse Event (AE) Reporting:
• Follow local processes, procedures and systems that are in place for tracking, processing, and conducting follow up (FUP) for AEs and other safety information reportable to PPS from spontaneous and solicited sources.
• If fulfilling the role of triage subject matter expert (SME), manage, triage and prioritise all information received into the PV inbox as required.
• Review ICSR data for completeness, identify any additional information or clarification required (e.g. lot/batch #, age or age group, medically relevant information) and ensure follow-up is completed as required for all case types including post-marketing observational studies (PMOS).
• Enter data accurately into ECR as per local and global procedures, and forward to PPS in a timely manner.
• Perform quality control (QC) of ICSRs entered in Affiliate AE tracking log and cases sent to PPS.
• If fulfilling the role of reconciliation SME, complete weekly or monthly ICSR reconciliation with interacting departments and/or partner companies (if applicable) and act upon any discrepancies.
• Request additional follow-up information from multiple sources as per global and regulatory requirements.
• If fulfilling the role of Regulatory Authority (RA) SME, monitor and assess ICSRs for reportability to the regulatory authority (RA) and ensure QC of reporting decisions to local regulatory authority.
• If fulfilling the role of literature SME, review local medical or scientific literature not included in PPS global literature to identify possible AEs or special situations reportable to PPS and forward in a timely manner to PPS.
• If fulfilling the role of source data verification (SDV) SME, oversee process for periodic quality control (QC) sampling of records without AEs for AE identification as applicable ( e.g. product quality complaints (PQCs), medical enquiries, partner/ vendors etc.).
• Ensure that patient confidentiality and privacy in accordance with local applicable laws and regulations are adhered to, and if necessary, perform redaction of patient information from Adverse Event (AE) forms and medical records (i.e., discharge summaries, physician notes, laboratory data, etc.) before information is transmitted to PPS.
• Ensure product complaints are reviewed for AEs, and forward any AEs identified to PPS.
• Ensure product complaints are forwarded to Quality Assurance (QA) within 24 hours of receipt.
• If fulfilling the role of reconciliation SME, complete reconciliation between local Quality Assurance (QA) and PV, ensuring that all AEs have been identified and reported.
Quality System / Standard Operating Procedures (SOPs):
• Maintain proficiency in global and local SOPs.
• Author, review and / or provide input into local SOPs as required.
• Pro-actively identify process areas requiring improvements; contribute to local process improvement initiatives.
Safety Data Exchange Agreements (SDEA) and other PV Agreements:
• Maintains compliance with local agreements and ensures the content of local SDEAs and other PV agreements conforms to AbbVie standards per Q-15-01-018 and local requirements, including reconciliation between partner companies and vendors.
• Notify PV team leaders and Head of PV of deviations to local PV-related procedures.
• Follow the Corrective Action and Preventative Action (CAPA) process as outlined in QCA01-01-022 for the reporting and investigation of exceptions (nonconformance, potential nonconformance and planned deviations).
• Maintain awareness of local PV legislation.
• If fulfilling the role of metrics SME, report compliance metrics and information to PPS or Research and Development Quality Assurance (RDQA) PV and Regulatory affairs (RA) QA (RDQA PV & RA QA) within the required timelines. Generate ad hoc metrics as needed and chair KPI meetings with Medical Director and PV management team, as required.
• If fulfilling the role of RA SME, ensure PPS Compliance and Learning (C&L) and Affiliate Vigilance Excellence (AVE) are promptly notified of any changes to local legislation; ensure formal documentation and notification to AVE and PPS of local reporting requirements for both ICSRs and aggregate reports, provide updates to these requirements per changes in local legislation, and review and confirm these requirements at least annually.
• If fulfilling the role of clinical SME, ensure submission of periodic reports/Development Safety Update Report (DSUR) summaries to Ethics Committees/investigators as applicable in line with local regulations.
• Identify and escalate compliance issues in a timely way to line manager.
• Track late ICSRs in the late case register; conduct investigation of root cause for each late case and establish corrective/preventive action as applicable.
• Comply with global and local PV training requirements in ISOTrain and other mandatory training as required by PPS.
• If fulfilling the role of training SME, ensure affiliate personnel are trained on relevant PV responsibilities at least annually as applicable and maintain appropriate training records; ensure partner and vendor staff is trained according to local contract requirements, and document appropriately.
Audits and Inspections:
• Ensures that any Regulatory Authority communications regarding inspections are forwarded to the required Head of PV ANZ and PV Team Leaders as soon as received.
• Ensures that any local responses/corrective actions are tracked and completed according to schedule and collaborates in a timely manner with PPS for any global response/corrective action.
• Maintain awareness of and comply with business continuity plan to allow for continuation of critical business processes for PV.
This function is located in Mascot, Australia.
• Medical, pharmacy or life-sciences degree (or equivalent)
• Experience working in the pharmaceutical industry in a PV role
• Demonstrated attention to detail
• 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 RAs
• High customer orientation
• Ability to prioritise and work to strict timelines on a daily basis
• Good knowledge of relevant PV legislation and best practices
• Good understanding of medical concepts
• Excellent verbal and written communication with internal and external customers
• Ability to work effectively as a member of the PV team and broader Medical department