• Creates and implements the systems of internal regulatory documents and standards based on the legislation requirements and regulatory standards of the pharmacovigilance and quality;
• Provides support in implementing the development, maintenance, and updating of the master file of the pharmacovigilance system;
• Provides/maintains a system of collecting, processing, and reporting information of the medicines safety profile;
• Provides/maintains a system of collecting, processing, and reporting other safety information, creates all necessary safety reports (PSUR, Monthly reports, RMP other);
• Support in performing signal detection activities and risk management for contract products;
• Conducts screening of regulatory authorities' sites (EMA, FDA, other) and makes a weekly literature search (Pubmed) for the information on the safety;
• Interacts with foreign partners in the field of pharmacovigilance, including Safety Data Exchange Agreements management

- Ensures mechanisms are in place to facilitate oversight of all adverse event reporting (from clinical studies and marketed use) to ensure standards of safety reporting within the MC are met.

- Ensures up to date organization charts, 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 from clinical studies, 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

- 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 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

- 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 an afterhours process is in place and tested, e.g. to respond to regulatory authority questions

- 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.

- Support Company functions relating to Patient safety and Medical Information issues

• Creates and implements the systems of internal regulatory documents and standards based on the legislation requirements and regulatory standards of the pharmacovigilance;
• Provides support in implements the development, maintenance and updating of the master file of the pharmacovigilance system;
• Provides / maintains a system of collecting, processing and reporting of information of the medicines safety profile;
• Support in performing signal detection activities and risk management for Alpen Pharma AG products;
• Conducts screening of regulatory authorities' sites (EMA, FDA, Swissmedic) and makes a weekly literature search (Pubmed) for the information on the safety of the Company's and partners' products portfolio;
• Interacts with foreign partners in the field of pharmacovigilance, including Safety Data Exchange Agreements management;
• Interacts with affiliates in all markets concerning all questions and on a monthly basis performs reconciliation procedure with affiliates to have oversight on activities performed and its compliance with generation of monthly compliance report etc.

Providing pharmacovigilance support to СH staff in Ukraine, Moldova (SSA with Romania), Georgia, Azerbaijan, Uzbekistan, Turkmenistan and Tajikistan to ensure compliance with GSK ethical and scientific standards.

Day to day management of pharmacovigilance for marketed products including all Consumer Healthcare products. This includes compliance with all local regulations and GSK global pharmacovigilance requirements, and includes but is not limited to:

• Collection of adverse events (AEs), recording in the country register and reporting of SAEs to Central Safety Depts;
• Timely reporting of AEs/SAEs to the local regulatory authority as required;
• Submission of PRBERs to Regulatory Authorities as required;

Training of all operating company staff in AE reporting and other.

Taking part in quality assessments of Ukrainian distributors and other third parties as an internal auditor.

As QA Manager:

• Developing and strengthening the Quality Assurance function by: analyzing and localizing (if applicable) global SOPs; developing local SOPs; implementing all applicable SOPs in the Ukrainian market.
• Providing assessment of the quality system documentation for compliance with the requirements established in Ukraine and corporate policies (conformity assessment of the registration certificate, test methods, the conclusions on the recognition of GMP certificates, the manufacturer's quality certificate, etc.);
  
• Support in receiving conclusion of quality of imported medicinal products to Ukraine, including: verification of all documents received from manufacturer; checking of certificates of analysis for finished products; receiving the samples of products for laboratory control, if needed; work with distributors / laboratories / manufacturers concerning all procedures related with quality control of medical products; work with any complaints received from Health Authority.
• Leading the procedure for receiving recognition of GMP certificates in State Administration of Ukraine on Medicinal Products.

As PV Specialist:

• Leading the PV function via managing collection, processing, documentation, reporting and follow-up of all adverse events reports for all Novartis products from all sources: consumers, employees, internet sources, contractors, post-marketing studies, spontaneous reports, registries, Health Authorities, commercial programs, etc.;
• Accountable for reporting/submission/distribution of safety reports/updates/information (e.g. , SR, PSUR, changes in risk/benefit);
• Development and assurance of validity for local SOPs and global SOPs implementation
• Accountable for preparation of the PV training materials

Ensure training and oversight of the OTC employees, as applicable, and others.