Patient Safety Lead

OBJECTIVE

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to Patient Safety. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of noncompliance.
• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.

RESPONSIBILITIES

• Ensures compliance with both AZ requirements and global and local regulatory requirements for patient safety within CAMCAR and ensures corrective and preventive actions are taken in event of local non-compliance.
• Ensures that all local information relating to the pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF).
• Ensures that up-to-date organization charts, job descriptions, training records and curriculum vitae are available for local Patient Safety Personnel.
• Maintains oversight of all safety related processes, issues and brand activities within their country.
• Ensures that an after-hours process is in place, to ensure a customer can report an AE, to respond to regulatory questions, to facilitate local health authority unscheduled inspections, and to facilitate the unblinding of local studies if that has been agreed as local safety responsibility.
• Ensures that appropriate cover is in place so that all activities continue to be performed within the required timeframes when the PSM is out of the office, on holiday, unexpected leave, etc.
• Maintains an in depth knowledge of their local authority, the regulations, expectations and regulatory authority contacts and ensures that upcoming changes in legislation/guidance are notified to their regional lead for discussion and escalation to relevant stakeholders in GRAPSQA as required.
• Maintains current knowledge of the marketed status of products in their local country and reference documents such as the summary of product characteristics or other local market data sheet.

• Possesses working knowledge of applicable procedural documents as well as knowledge of AstraZeneca products sufficient to enable training and annual refresher training of all local staff and locally engaged vendors, in safety processes and procedures.
• Ensures that when transfer of pharmacovigilance data occurs within an organization or organizations, the mechanism should be such that there is confidence that all notifications are received and that a confirmation and/or reconciliation process should be undertaken.
• Ensures that the local safety agreements are monitored and maintained.
• Ensures that filling and archiving practices are followed the relevant AstraZeneca policy and that there is no destruction of safety-related documentation without prior reference to local Patient Safety.
• Ensures that local process, procedures and systems are in place for recording, processing, following up and translation of AEs from spontaneous and solicited sources, AEs from local non-interventional studies and SAEs from local interventional clinical studies.
• Ensures that the local regulatory requirements are defined with respect to reporting ICRS to local authorities, local ethics committees and investigators and ensures that these reports are tracked (tracking conducted by clinical hub used), so that details of when a report was issued and to whom are available.
• Ensures that local process are in place with respect to submission and tracking of periodic safety reports to local Health Authorities, investigators and ethics committees.
• Is responsible for assessment of all non-serious AEs from spontaneous sources and the upgrade of relevant events to serious in accordance with AstraZeneca always serious list & designated medical events (DME) list.
• Reviews local language medical or scientific literature to identify possible case reports, and forwards in a timely manner to AZ Patient Safety Data Entry Site (DES).
• Is trained in the use of Global Tracking Tool, JASPER, unless the tool is not available in the MC.
• Ensures that relevant GSP is notified of potential safety signals and issues and any unsolicited report of unexpected benefit occurring with Approved Products are forwarded to DES and GSP/CPL.
• Ensures that the local legal team are informed of threatened, possible or actual legal action.
• Ensures a local Business Continuity Process (BPC) for Patient Safety is in place and tested at least annually.
• Ensures that local process, procedures and systems are in place for recording, processing, following up and translation of AEs* from spontaneous sources and serious adverse events from clinical studies. * Including drug exposure during pregnancy, overdose, lack of effect, medication errors or combined product quality complaints reports (complaints associated to one or more suspected adverse drug reactions, lack of effect or medication error or vice versa).
• Ensures adverse event data is communicated to the data entry site (TCS-TATA Consultancy Services) in compliance with Patient Safety Standards and other relevant AZ procedural documentation.
• Ensures that appropriate tracking systems are in place to capture:
• o     The date that case reports were received at AstraZeneca
• o     Date forwarded to the AZ Patient Safety Data Entry Site
• o     Attempts made to obtain follow-up information
• o     Date follow-up data is received
• o     Date submitted to regulatory authorities, investigators or ethics committees where applicable.
• Takes necessary corrective actions locally in respect of late reporting from within the MC.
• Liaises with internal and external groups on safety related issues where applicable.
• Ensuring appropriate levels of resource to complete GVP activities appropriately.
• Providing/coordinating training and coaching in the related GVP for the MC QMS.
• Identifying/agreeing areas of compliance risk and follow-up of any issues.
• Ensuring GVP self-assessments conducted according to plan
• Monitoring KPIs in the related GVP area and propossing remedial
• Establishing improvement priorities
• Monitoring internal/external factors such as emerging regulation or shifts in regulatory enforcement
• Identifying trends and communicating identified risks

QUALIFICATIONS

Formal Education

• University degree or equivalent with medically or scientifically qualified or proven competence in the drug safety or regulatory area.

Other Skills

• Good knowledge of international guidelines ICH/GCP/GVP-
• Basic knowledge of GMP/GDP.
• Excellent knowledge of relevant local legislation.
• Good medical knowledge in AZ Therapeutic Areas.
• Good understanding of the Drug Development Process.
• Good understanding of the Clinical Development Process.
• Good understanding of the Clinical Study Process.
• Advanced English skills.

• Excellent organizational , analytical, communication, negotiation and presentations skills.
• Excellent ability to prioritize and handle multiple tasks.
• Excellent ability to act quickly.

• Excellent ability for attention to details.
• Excellent ability to work according to global standards.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.