PV-QA-MedInfo Specialist for frontier markets
- Ensure correct certificate of analysis flow for the goods delivered to respective AZ regional business unites;
- Ensure that received certificates of analysis meet the local requirements for further receipt of sale permissions;
- Cooperate with regulatory department to ensure the delivered goods comply with the adjusted for market requirements (local pack; mock-up etc.). Participate in monthly meetings;
- Coordinate translation of certificates of analysis for batches of goods delivered to business unites upon request;
- Communicate with the manufacturing sites to implement relative changes to the CoAs;
- Provide support and advice during cross functional investigations/projects and oversees delivery of quality investigations-including auditing processes and reporting;
- Keep abreast of all related quality legislation and compliance related issues;
- Provide support during audits and regulatory inspections and resolution of follow up actions. Best practice sharing of audit/inspection outcomes
- Provide Quality Assurance support to other functions and promote Quality Excellence
- Register, inform, track follow-ups of the complaints related to supply, quality, product security;
- Train the involved parties on complaints and their reporting deadlines;
Back-up role of GxP lead in AZ Ukraine:
- Establish, implement key elements of Commercial Quality Management system (C-QMS) covering all GxP related activities and business needs across UA Market;
- Promote continuous Improvement of the Commercial Quality Management System, enhancing commitment to quality and improving profitability;
- Perform and/or ensure GxP self-inspections by each of the Quality Leads, as appropriate, and follow up
- Guide development of quality procedures in multiple areas at own site, review and approve locally generated procedures and provide input into the global/regional procedures as requested;
- Perform critical trouble shooting, monitor and drive quality issues to resolution within AZ UA MC and third parties
- Monitor Key Quality Compliance and Performance Indicators across all GXP areas and propose remedial or improvement actions consistently identified in all areas, identify trends and report status to management on identified risks;
- Ensure high standards of quality systems in all GxP related areas;
- To provide GxP assurance to the Country President according to the AstraZeneca Global Quality Compliance manual;
- Support and maintain Business Continuity Plans as applicable to the Quality function
Patient Safety & Medical Information
- Ensures mechanisms are in place to facilitate oversight of all adverse event reporting (to ensure standards of safety reporting within the MC are met.
- Ensures up to date, job descriptions, curriculum vitae (CVs) and training records are available for the local MC Patient Safety and MI personnel
- Ensures that local processes, procedures and systems are in place for recording, processing, conducting follow up and translating adverse events from spontaneous sources and serious adverse events including drug exposure during pregnancy, overdose, and lack of effect, medication errors or product quality complaint reports.
- Ensures adverse event data is communicated to the data entry site in compliance with Patient Safety Standards and other relevant AZ procedural documents
- Ensures medical information requests are entered in GMIP and answered in timely manner
- Possesses working knowledge of applicable procedural documents as well a knowledge of AstraZeneca products sufficient to enable training of local staff in safety processes and procedures
- Maintains current knowledge of local authority contacts, reporting requirements, ongoing studies, marketed status of products in the local country, local licensing agreements, safety related issues and reference documents such as Periodic Safety Update Report, Summary of Product Characteristics (SPC) or other market data sheet
- Possesses knowledge of local reporting requirements and process of expediting reports to the local regulatory authority
- Ensures local documentation of submission decision (for regulatory authority reporting) recorded in local tracking system and that local compliance data is collated.
- Takes necessary corrective actions locally in respect of late reporting from within the MC.
- Ensures GVP processes are in place accordingly to GxP in case of GVP lead absence
- Ensures local language medical or scientific literature is reviewed to identify possible case reports, and that any reports are forwarded in a timely manner to the central Data Entry Site.
- Ensures any safety issues/signals identified by regulatory authorities, media or other local sources or safety related changes to local regulatory requirements are communicated to Global Patient Safety (such as the Global Safety Physician for the product)
- Ensures that the filing and archiving of safety related data is performed according to AZ global policy and national requirements, whichever is longer/the more stringent, ensuring no destruction of safety related documentation without prior reference to Global Patient Safety.
- Liaises with internal and external groups on MI and safety related issues where applicable.
- Ensures a local Business Continuity Process (BCP) for Patient Safety and Medical Information Service are in place.
- Maintain highest ethical standards and work in a spirit of AstraZeneca Code of Conduct and Pharma Code, following rules & norms set by corporate policies
- Ensure that all conducted activities are done in accordance with local legislation and corporate standards.
- Report all accidents (including car accidents), occupational illness, incidents and other abnormal deviation to line manager or local SHE Coordinator.
- Maintain highest ethical standards and work in a spirit of AstraZeneca Code of Conduct and, following rules & norms set by corporate policies that the MC PS and MI was acknowledged about
- Training programs applicable of GxP, Quality Management System and management of medical information inquiries.
- Never be engaged in promotion of any products, nor leave samples for HCPs.
- Enforce AZ compliance culture
- Leadership and People management skills
- Ability to form partnerships, build and maintain relationships
- To be involved in AZ global and/or regional projects of Patient safety and Medical Information.
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 authorisation and employment eligibility verification requirements.