Drug safety specialist lithuan, Vilnius

Our Client is the Representative Office in Lithuania of a global innovative healthcare company that provides solutions to the evolving needs of patients worldwide.

 The company is strengthening its team in Lithuania and currently looking for the

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:

1. 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.
2. 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.
3. 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.
4. 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.
5. Work with other local/global PVO associates to ensure accurate evaluation of safety data.
6. Interact and exchange relevant safety information with LHA, PVO associates, other functional groups and third party contractor, if applicable.
7. Survey and monitor national pharmacovigilance regulations and provide update to global PVO organization.
8. Develop, update and implement local procedures to ensure compliance with PVO global    procedures and national requirements.
9. Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
10. 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.
11. Management and maintenance of all relevant PVO databases.
12. 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.
13. 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.
14. Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
15. Manage and maintain efficient PVO filing and archive system.
16. 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.