AbbVie Senior Pharmacovigilance Associate (6 month contract) in Sydney, Australia
In this role you will 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.
Key Responsibilities Include: Adverse Event (AE) Reporting:
* Follow local processes, procedures and systems that are in place for tracking, processing, and conducting * follow up 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 and 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 both clinical and post‐marketing * 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 language 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. Product Quality Complaints:
* 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:
* Maintain compliance with local agreements, including reconciliation between partner companies and * vendors. * Ensure the content of local SDEA and other PV agreements conforms to AbbVie standards per Q‐15‐01‐018 and local requirements. * Submit all local SDEAs to PPS, C&L for review prior to finalisation. * Submit all other local PV agreements to PPS for review prior to finalization, in the event these agreements contain variations from the PV Agreement Language template. * Responsible for requesting or providing a copy of all AE files for local product acquisition and divestitures. * Submit all approved local SDEAs and other PV agreements in the PV agreements database within thirty (30)days of contract approval. * Ensure any changes to local PV agreements are updated in the PV agreements database within thirty (30) * days such as but not limited to changes in contact information or terminations of PV agreements. * Responsible for maintaining the inventory of all local SDEAs and other PV agreements and their respective * product list and status within the PV Agreements database. * Ensure a local tracking system is in place to monitor compliance to local safety data exchange (SDE) * timeframes. * At a minimum annually, or upon request of C&L, reconcile local SDEAs and other PV agreements with the * PV agreements database, and complete an attestation documenting this review in the PV agreements * database. * Process ICSRs in compliance with local agreements, including reconciliation between partner companies. Compliance:
* Notify PV team leader and Head of PV of deviations to local PV‐related procedures. * Follow the 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 monthly compliance metrics and information to PPS or Research. * and Development Quality Assurance (RDQA) PV and Regulatory Affairs (RA) QA within the required * timelines. Generate ad hoc metrics as needed and chair quarterly KPI meeting with Medical Director and PV management team. * 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. Training:
* 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 and contractors are trained on relevant PV * responsibilities at least annually as applicable and maintain appropriate training records; ensure partner and vendor staff are trained according to local contract requirements, and document appropriately. Audits and Inspections:
* Implement audit or inspection corrective / preventive action plan within required timelines. * Ensure that any RA communications are forwarded to the required PPS personnel and that any * responses/corrective actions are tracked and completed according to schedule * Contribute to ensuring PV inspection readiness at the affiliate level at all times. Business Continuity:
* Maintain awareness of and comply with business continuity plan to allow for continuation of critical * business processes for PV. INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS:
* Affiliate Medical, Regulatory Affairs, QA and Customer Service personnel * Affiliate Marketing, Sales and Operations personnel * TGA and Medsafe/CARM * Global PV including headquarters staff and regional AVE Associate Director * Healthcare practitioners, consumers and patients. AUTHORITY AND REPORTING LINES:
* This position reports into the Head of PV or a PV team leader. LOCATION:
* This function is located in Mascot, Australia.
* Medical, pharmacy or life‐sciences degree (or equivalent). * At least 2 years of experience working in the pharmaceutical industry in a PV role. * Effective decision maker with the ability to assess impact of actions taken locally on the global PV system. * Proven ability to lead a team; ability to lead a project from planning to completion with minimal Supervision. * Demonstrated ability to take the initiative and challenge the status quo. * Holds self and others accountable for actions. * 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. * Ability to work effectively as a member of the PV team and broader Medical department. CRITICAL SUCCESS FACTORS:
* Strong leadership skills. * Builds and maintains strong relationships with non‐affiliate colleagues (e.g. Medical Information, Regulatory Affairs, Commercial). * Learns fast, grasps the "essence" and can change course quickly where indicated. * Acts consistently within AbbVie’s ethics, obligations and local laws. * Focused on compliance; identifies, manages and escalates issues in a timely manner.
Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: Australia-New South Wales-Sydney
Organization: Research & Development
Req ID: 1705275