1632
- Skelbimas
- Atlygis/Miestas
- Apie įmonę
Based in a Global Drug Safety Unit (GDSU) in Vilnius, Pharmacovigilance Specialist together with a Head of GDSU and other associates sets up and maintains an efficient pharmacovigilance system in compliance with the national and European Union (EU) regulations for medicinal products, food supplements and medical devices.
Main responsibilities and tasks:
· Ensures collection, processing, following up, assessment and archiving of all Adverse Drug Reactions (ADR) reports from all sources involving external service providers as appropriate;
· Ensures timely entering the data of ADR/event reports to the European Medicines Agency (EMA) to EudraVigilance, U.S. Food and Drug Administration (FDA) and any other Health Authorities systems and companys database;
· Ensures permanent monitoring of EudraVigilance system with regards to the safety data of medicinal products of the represented Marketing Authorisation Holders (MAHs);
· Supports preparation of Periodical Safety Update Reports (PSUR) and Periodical Adverse Drug Experience Report (PADER);
· Ensures timely submission of PSURs/PADERs to the central EU/US repository and, if required, to local Health Authorities;
· Ensures preparation of Risk Management Plans (RMP), as applicable;
· Ensures establishment, review, update and termination of the Safety Data Exchange Agreements (SDEA) and/or Pharmacovigilance Agreements, as applicable with the business partners of the MAHs;
· Screens ADR reports of the medicinal products for represented MAHs in the global scientific literature;
· Monitors Health Authorities websites for possible safety referrals and signals regarding the products of represented MAHs;
· Monitors all pharmacovigilance related regulations and informs immediately about all important changes;
· Supports preparation for possible pharmacovigilance inspections by Health Authorities and audits by represented MAHs or internally;
· Supports the implementation of corporate and local SOPs and WIs for pharmacovigilance related activities;
· Supports deviations management, that relates to pharmacovigilance activities;
· Supports the implementation of the additional safety measures (i.e. Direct Health Care Professional letters, etc.);
· Ensures safety signal detection and management for the medicinal products;
· Supports preparation of adequate pharmacovigilance training for local personnel and, if needed, the Contract Research Organization (CRO) staff;
· Performs comparison of the Companys products safety information versus the reference product, issues the Company Core Data Sheet (CCDS) and timely informs relevant Regulatory Affairs functions about the need of implementation via the safety variations;
· Ensures timely update of the product information data in EU Article 57 data base (XEVMPD) for the Company products;
· Supports other company departments in all drug safety related issues.
Requirements to the Candidates:
- Graduate in medical science, veterinary medicine, pharmacy, biology, biochemistry or similar discipline
- Skills of the management of pharmacovigilance systems as well as expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences
- Good communication and writing skills of English language, fluent in Lithuanian, good communication and writing skills of German language would be an advantage
- Good computer skills
- Ability to coordinate projects involving external parties
- Quality and focus oriented
- Ability of working in a team as well as individually
- Ability to communicate efficiently
To apply, please send your CV and Motivation Letter to Consultant Rūta Aladavičienė, e-mail: r.aladaviciene@executivesearch.lt
Only successful candidates will be notified. Information received will be treated as strictly confidential.
€
2805 - 3140
Vietovė
- Vilnius, Vilniaus apskritis, Lietuva
Laikas
- Visa darbo diena
Įgūdžiai
Kalbos
- Anglų
- Lietuvių
Kontaktinis asmuo
Rūta Aladavičienė
Rūta Aladavičienė
SanoSwiss is a pharmaceutical company founded in Lithuania in 2009, operating in the Baltic States as a marketing authorisation holder and distributor for medicinal products and food supplements.
Since 2017, SanoSwiss is proud to be a part of Rivopharm Group, headquartered in Switzerland. Rivopharm is a company that manufactures, develops and markets generic medical products in more than 50 countries worldwide.
The Global Drug Safety Unit (GDSU) established in SanoSwiss acts as a central hub for drug safety management. GDSU is leading comprehensive global pharmacovigilance operations in close cooperation with local units and numerous companies partners, dedicated to maintaining the highest levels of safety and efficacy in pharmaceutical care.
Daugiau jūsų paiešką atitinkančių rezultatų:
Sales Support Specialist
Service delivery specialist in Cross Border Payments (Maternity Cover)
Direktorius (-ė)
Lietuvos nacionalinė vežėjų automobiliais asociacija LINAVA
Vilnius
€ 2900 – 3200
Galioja iki: 2025.04.30
Vilnius
€ 2900 – 3200
Galioja iki: 2025.04.30
Privatus mokytojas
Komercijos vadovas (-ė)
Individualios priežiūros darbuotojų koordinatorius(-ė)