AbbVie Head of Pharmacovigilance (Australia & New Zealand) in Sydney, Australia
Fulfil the responsibility for the coordination and execution of all aspects of pharmacovigilance (PV) to ensure that all of AbbVie’s statutory and ethical responsibilities are met. Act as the affiliate’s main contact point for PV matters with the Therapeutic Goods Administration (TGA), Medsafe, CARM, and AbbVie Global PV. Provide strategic leadership to manage and support the PV team to meet all global and local PV responsibilities.
Note: Pharmacovigilance and Patient Safety (PPS) has primary responsibility for defining the roles and responsibilities of Affiliate Safety Representatives (ASRs) and this is done through SOP Q-15-01-008. This template job description should be reviewed annually to ensure that it is consistent with the SOP.
* * Leadership and oversight of PV team: * * Lead and motivate the PV team to achieve and maintain high levels of compliance. * Support recruitment, on-boarding, training and development, performance management, and succession planning of appropriately skilled PV staff. * Provide the required coaching and mentoring to develop the PV team for high performance. * Maintain oversight of all required PV regulatory reporting compliance in a timely manner. * Provide comprehensive compliance metrics to the Medical Director (MD) at least quarterly to ensure full visibility of potential compliance issues. * Advise the business on the PV impact of local organized data collection (ODC) programs. * Escalate compliance issues in a timely manner to Affiliate Vigilance Excellence (AVE) and the MD to ensure appropriate mitigation is implemented. * Monitor and forecast PV workload to identify, mitigate and escalate potential PV resource and non-compliance issues. * Identify periods of high PV workload and manage PV resource appropriately to address them. * Support and lead process improvements to optimize the affiliate PV system and make best use of PV resource. * Work collaboratively with regional affiliates to ensure consistency of approach across groups. * Build and maintain effective business relationships across the affiliate to support the implementation of safety standards. * Provide high quality and consistent input to development of local safety initiatives and programs. * Plan and deploy skilled resources against project priorities. * Maintain an environment of continuous improvement within the PV team and contribute to continuous improvement initiatives across the region and globally with PPS.
Quality System / Standard Operating Procedures (SOPs):
- Ensure local processes and procedures are in place to clearly define PV responsibilities within the affiliate in line with global SOPs and local regulations.
- Ensure all local PV quality documents are reviewed and updated as applicable at minimum every 2 years.
- Ensure all required documents related to PV departmental activities are retained according to SOPs and regulatory requirements.
Review any changes to global quality documents and perform and track impact assessment on local quality documents; implement change management in a timely manner according to global requirements.
- Ensure compliance with the CAPA process as outlined in QCA01-01-022 for the reporting and investigation of exceptions (nonconformance, potential nonconformance and planned deviations).
- Ensure a local tracking system is in place to ensure timely submissions of adverse events (AEs) to PPS.
- Ensure reporting of both clinical and post-marketing individual case safety reports (ICSRs) and periodic reports to the RA and ethics committees as required.
- 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
- Maintain awareness of local post-marketing and clinical PV legislation
- Ensure PPS, minimally PPS Compliance and Learning (C&L) and AVE are promptly notified of any changes to relevant 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.
- Coordinate affiliate review and submission of PSURs & DSURs.
- Ensure any changes to affiliate safety personnel are communicated to the RA (i.e. nominated contact person for PV), PPS and AVE in a timely fashion.
- Complete AE reconciliation with interacting departments and/or partner companies (if applicable) and act upon any discrepancies
- Review and confirms regulatory reporting requirements at least annually
Adverse Event Reporting:
- Ensure that local processes, procedures and systems are in place for tracking, processing, and conducting follow up for AEs and other safety information reportable to PPS from spontaneous and solicited sources.
- Ensure comprehensive data collection and follow-up (eg. Lot/batch #, age or age group, medically relevant information) for all case types including post-marketing observational studies (PMOS).
- Ensure local language medical or scientific literature, not included in PPS global literature review, are reviewed to identify possible adverse events or special situations reportable to PPS, and that any reports are forwarded in a timely manner to PPS . .
- Implement an appropriate local quality control (QC) procedure to ensure quality of information entered in Affiliate AE tracking log, cases sent to PPS and of reporting decisions to local regulatory authority.
- Ensure a local process is in place forperiodic 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, performed by redaction of patient information from Adverse Event (AE) Forms, medical records i.e., discharge summaries, physician notes, laboratory data information, etc. before information is transmitted to PPS.
Product Quality Complaints:
- Ensure a local process is in place to forward PQCs to Quality Assurance (QA) within 24 hours of receipt by PV.
- Ensure PQCs are reviewed for AEs, complete AE reconciliation and ensure any AEs identified are forwarded to PPS
ODC Programs (Patient Support, Market Research, and Social Media Programs):
- Ensure that all ODC programs are assessed for impact to AE generation and PV requirements are in place and in line with global and local SOPs.
- Ensure that any new programs or any significant changes in existing programs are tracked and updated in the PPS program inventory.
- Ensure training on PV obligations is conducted for all Abbvie and service provider staff involved in ODC programs with annual refresher training.
- Monitor the service provider to ensure PV obligations are being fulfilled, including appropriate collection, follow up and reconciliation of safety information according to local procedures.
- Ensure vendor quality assessments of relevant service providers are performed.
- Ensure that proposed audits of ODC program service providers/vendors are communicated to AVE and RDQA PV & RAQA prior to audit.
- Support local QA and RDQA PV & RA QA to conduct vendor audits and complete vendor Corrective Action Plans (CAPs).
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 finalization.
- Submit all other local PV agreements to PPS for review prior to finalization if these agreements contain variations from the PV agreement language templates.
- 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 for central tracking within thirty (30) days of contract approval.
- Ensure any changes to local PV agreements (e.g. changes in contact information; terminations) are updated in the PV agreements database within thirty (30) days.
- Responsible for maintaining the inventory of local SDEAs and other PV agreements and their respective product list and status within the PV Agreements Database
- Maintain the inventory of all local SDEAs and other PV agreements within the PV agreements database, including current status and a list of applicable products.
- Ensure a local tracking system is in place to monitor compliance with local safety data exchange 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.
- Maintain a version-controlled training matrix/plan for local PV personnel which includes, but is not limited to, local SOPs, local regulations and references to the global affiliate PV courses allocated in ISOTrain.
- Ensure training compliance with PPS and local PV training requirements in ISOTrain and other mandatory training as required by PPS.
- Ensure all Affiliate employees and contractors for all countries the ASR is responsible for (including Global or Area staff based at the Affiliate) are aware of their responsibility to complete annual adverse event identification and reporting training. This PV training is to be undertaken at least annually, and appropriate training records shall be maintained. Ensure this training is completed.
- Ensure that any training of partner company and vendor staff is completed according to local contract requirements, and appropriately documented.
Audits and Inspections:
- Lead the audit / inspection preparations for internal PV audits and RA PV inspections.
- Act as the key affiliate contact for both internal PV audits and RA PV inspections.
- Lead the review of documents prior to and during internal PV audits and RA PV inspections.
- 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.
- Ensure PV inspection readiness at the affiliate level at all times.
- Represent PV as a member of the Affiliate Risk Management Team per Q-15-01-008-W004.
- Review all risk management plans and PSURs to obtain information on the risk/benefit profile of products.
- Monitor the risk/benefit profile of local products and communicate changes or concerns to the MD, PPS Product Safety Team Lead and the QPPV (for products marketed in the EEA) for evaluation.
After Hours Availability:
- Ensure that a process is in place for reporting of AEs after hours, and testing is documented at least once every 3 months.
- Ensure local RAs are provided with up-to-date after-hours contact information for key PV staff (e.g. nominated contact person for PV).
- Ensure that a disaster recovery /business continuity plan is established in a risk-based manner 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 affiliate MD.
- LOCATION: *
This function is based in Mascot, Australia.
- Medical, pharmacy or life-sciences degree (or equivalent)
- 5 - 10 years of experience in PV essential; experience working in the pharmaceutical industry is strongly preferred
- Minimum 2 years of experience in management of direct reports
- Extensive experience in conducting training
- Knowledge of Australian and New Zealand PV regulations
- Experience using ARISg or similar global safety database desirable
- Demonstrated attention to detail
- Excellent written and spoken communication and presentation skills
- Effective decision maker with the ability to assess impact of actions taken locally on the global PV system
- Fluency in written and oral English in order to facilitate communications with PPS, regional Medical, other global functions, and RAs
- High customer orientation
- Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
- Sound judgment, strong planning and organizational skills, and the ability to get things done
- Demonstrated strong sense of urgency
- Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety
CRITICAL SUCCESS FACTORS:
- Builds and maintains strong relationships with non-PV colleagues (e.g. Medical Information, Regulatory Affairs, Commercial)
- Learns fast, grasps the "essence" and can change course quickly where indicated
- Raises the bar and motivates others to a higher standard of performance
- Creates a learning environment, open to suggestions for improvement
- Embraces the ideas of others, nurtures innovation and manages innovation to reality
- Deals comfortably with ambiguity and uncertain risk
- Acts consistently within AbbVie’s ethics, obligations and local laws
- Focused on compliance; identifies, manages and escalates issues in a timely manner
- Excellent organizational and project management skills
- Reacts quickly and effectively in a fast paced, dynamic environment
- Ability to establish clear direction, give and receive constructive feedback, and bring out the best in people
- Effective situational leadership and coaching skills
Job Classification: Experienced
Primary Location: Australia-New South Wales-Sydney
Organization: Research & Development
Travel: Yes, 15 % of the Time
Req ID: 1704977