to support management of DS&E operational processes in ensuring compliance with company global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of the company marketed and investigational products. Main functions: - Manage collection, processing, documentation, reporting and follow-up of all serious adverse events (SAE) reports for all company products from clinical trials, and all adverse events from Patient Oriented Programs, post-marketing studies (PMS), registries, and all Spontaneous Reports (SR) occurred in Lithuania.
- Transcribe, translate and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from Patient Oriented Programs, post-marketing studies (PMS), registries and all Spontaneous Reports) from source documents occurred in Lithuania onto safety systems accurately and consistently with emphasis on timeliness and quality.
- Record and track receipts, submissions and distributions of SAEs, SRs, local SUSARs, Periodic Safety Report Updates (PSUR) and Development Safety Update Report (DSUR) in cooperation with relevant departments.
- Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, domestic SUSAR, PSUR, Biannual SUSAR Listing, DSUR) occurred in Lithuania to Local Health Authorities (LHA) and/or clinical operations in cooperation with other departments.
- Work with other local/global PVO associates to ensure accurate evaluation of safety data.
- Interact and exchange relevant safety information with LHA, PVO associates, other functional groups and third party contractor, if applicable.
- Survey and monitor national pharmacovigilance regulations and provide update to global PVO organization.
- Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements.
- Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
- Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries and quality related complaints.
- Management and maintenance of all relevant PVO databases.
- Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
- Develop and update training materials for pharmacovigilance and ensure training of CPO associates on relevant PVO procedures for AE reporting, including field force and third party contractor, if applicable.
- Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
- Manage and maintain efficient PVO filing and archive system.
- Acts as DSR Deputy: functional (in terms of responsibility for PV system) and operational (in terms of managing the DS&E Team), etc.
Requirements for the candidates: - A degree in pharmacy, health discipline or life sciences
- Fluent in English (both written and verbal)
- Good working knowledge of Lithuanian
- Knowledge of other languages (beneficial)
- Knowledge of national and international regulations for pharmacovigilance
- Knowledge of pharmacological and medical terminology
- Excellent communication, interpersonal and negotiation skills
- Orientation to detail
- Quality and focus oriented
- Advanced Computer skills.
The company offers a dynamic and challenging work environment, a friendly and professional team and opportunity for personal growth. To apply, please send your CV and motivation letter, indicating position to: Delta Executive Search & Consulting lina.kalinauskaite@executivesearch.lt Confidentiality is guaranteed. Only successful candidates will be notified. |