As the Affiliate Safety Representative, fulfil the responsibility for the coordination and execution of all aspects of pharmacovigilance (drug safety) to ensure that all of AbbVie’s statutory and ethical responsibilities are met.
Act as the Affiliate’s main contact point for pharmacovigilance matters with the National Regulatory Authority and AbbVie Global Pharmacovigilance.
Set-up and maintenance of the local AbbVie pharmacovigilance system.
Ensure compliance of all local employees of their pharmacovigilance reporting responsibilities.
Oversight of PV
Maintains in a timely manner oversight of all required PV regulatory reporting compliance for the territories they are responsible for.
Provides comprehensive compliance metric reports to the Affiliate Medical Director (AMD) to ensure full visibility of compliance issues, at least quarterly.
Advises the business on the PV impact of local Organized Data Collection (ODC) programs (e.g. patient support programs).
Escalates compliance issues in a timely manner to International Pharmacovigilance Operational Excellence (IPEx) and the AMD to ensure appropriate mitigation is implemented.
Monitors and forecast PV workload to identify, mitigate and escalate potential PV resource and non-compliance issues.
Identifies periods of high PV workload and manages PV resource appropriately to address them.
Ensures local processes and procedures are in place to clearly define PV responsibilities within the Affiliate in line with Global SOPs and local regulations.
Ensures compliance with the Corrective Action and Preventive Action (CAPA) process for the reporting and investigation of exceptions (nonconformance, potential nonconformance and planned deviations).
Ensures a local tracking system is in place to ensure timely submissions of adverse events to AbbVie PPS.
Ensures reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic Reports to the Regulatory Authority and Ethics Committees as required.
Reports compliance metrics and information to PPS or Research and Development Quality Assurance (RDQA) PV & Regulatory Affairs (RA) QA (RDQA PV & RA QA) within the required timelines.
Reviews and confirms regulatory reporting requirements at least annually.
Monitors, notifies and assesses all draft and final hard PV intelligence in line with global timelines and requirements.
Co-ordinates Affiliate review and submission of PSURs, DSURs and other locally-required Aggregate Safety Reports.
Ensures changes to Affiliate safety personnel are communicated to PPS, IPEx and the Qualified Person for Pharmacovigilance (QPPV) (if applicable) and, if required by national legislation, to the Regulatory Authority, in a timely fashion.
Adverse Event Processing
Ensures that local processes, procedures and systems are in place for recording, processing, conducting follow up and translating adverse events (AE) and other safety information reportable to PPS from spontaneous and solicited sources and Serious Adverse Events (SAEs) from clinical studies.
Ensures comprehensive data collection and follow-up (e.g. lot/batch #, age or age group, medically relevant information) for all case types including Post marketing Observational Studies (PMOS).
Ensures local language medical or scientific literature, not included in PPS global literature review, are managed as detailed in the Global SOP.
Ensures 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 AE Forms, medical records i.e., discharge summaries, physician notes, laboratory data information, etc. before information is transmitted to PPS.
Implements 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.
Reconciliation of Safety Data and Product Complaints
Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures, and forwards any AEs identified to PPS.
Organized Data Collection Programs (Including Patient Support Programs, Market Research Programs, Social Media Programs)
Ensures 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.
Ensures that any new programs or any significant changes in existing programs are tracked and updated in the ODC inventories.
Ensures that proposed audits of ODC Programs service providers/vendors are communicated to IPEx and RDQA PV & RA QA prior to audit.
Supports 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
Maintains compliance with local agreements and ensures the content of local SDEAs and other PV agreements conforms to AbbVie standards and local requirements.
Responsible for requesting or providing a copy of all AE files for local product acquisition and divestitures.
Maintains a version-controlled training matrix/plan for local PV personnel which includes but is not limited to local SOPs, local regulations, and references the global Affiliate PV courses allocated in ISOTrain.
Ensures annual AE identification and reporting training and other mandatory training (as required by PPS) is provided, in compliance with PPS and local PV requirements, to all Affiliate employees and contractors in each country the ASR is responsible for (including Global or Area staff based at the Affiliate).
Ensures all Affiliate employees and contractors in each country the ASR is responsible for (including Global or Area staff based at the Affiliate) are aware of their responsibility to complete annual AE identification and reporting training. This PV training is to be undertaken at least annually, and appropriate training records shall be maintained. Ensures this training is completed.
Ensures training of Affiliate personnel on relevant PV responsibilities is undertaken at least annually, and that appropriate training records are maintained.
Ensures evidence of compliance related to this training is available to PPS upon request.
Ensures that any training of partner company staff is completed according to local contracted requirements, and appropriately documented.
Audits and Inspections
Acts as the key Affiliate contact for both internal PV audits, audit of service providers and Regulatory Authority PV inspections.
Ensures that any Regulatory Authority communications regarding inspections are forwarded to the required PPS personnel, Global Inspection Management and R&D Quality Assurance as per AbbVie procedures.
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.
Is a member of the Affiliate Risk Management Team.
Reviews all Risk Management Plans and PSURs to obtain information on the risk/benefit profile of products.
Monitors the risk/benefit profile of local products and communicates changes or concerns to PPS Product Safety Team (PST) Lead and the QPPV (for products marketed in the EEA) for evaluation.
After Hours Availability
Ensures that an after-hours process is in place for collection and reporting of AEs, tested at least once every 3 months and results are documented.
Ensures after-hours availability of the local person for pharmacovigilance, as required by local legislation.
Maintains up- to-date information on local Regulatory Authority out of hours contacts.
Ensures that a Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV. The plan should include provisions for events that could severely impact the organization’s staff and infrastructure in general or on the structures and processes for PV in particular including back-up systems for urgent exchange of information within an organization, amongst organizations sharing PV tasks as well as between marketing authorization holders and competent authorities.
Medical, pharmacy or life-sciences degree (or equivalent).
Experience working in the pharmaceutical industry in a drug safety role is strongly preferred for the Senior Pharmacovigilance Manager.
Preferably 2 years’ experience in a managing role.
Demonstrated attention to detail.
Excellent written and spoken communication and presentation skills.
Fluency in written and oral Dutch and English, in order to facilitate communications with Global Pharmacovigilance and headquarter functions as well as National Regulatory Authority.
High customer orienteation.
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.
Computer skills – MS Word, Excel, Adobe professional.
Flexibility, willing and able to work outside office hours.
Good knowledge of Dutch pharmacovigilance guidelines & legislation.