Regulatory Regulatory and Pharmacovigilance Specand Pharmacovigilance Specialist (Ref. č.: 1005505)

Ponuka práce

Dátum pridania: 17.8.2026

Práca

We're looking for an experienced professional in pharmacovigilance and regulatory affairs for medicinal products. If you're interested in joining our dynamic team and contributing to ensuring drug safety, we'd love to connect with you.
YOUR ROLE:
as Regulatory Affairs (RA) Specialist
- For assigned products and under supervision of Affiliate RA lead, timely prepare, submit and conduct appropriate follow-up of new Marketing Authorization and Life Cycle Management applications to the national competent authorities
- For assigned products provide regulatory guidance to multidisciplinary teams to ensure that development or maintenance activities to be performed in the context of approved business activities are performed in time and in compliance with applicable regulatory demands (legislation, guidelines) throughout the product´s life cycle. Ensure high quality labelling translation and compliant printed packaging materials of marketed products.
- Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons informed
- Ensure that processes, procedures and regulatory files are well documented in up to date and complete applicable archives, databases, repositories and trackers
- Supports implementation locally of new initiatives, , management tools or processes in cooperation with RA-EMEA
- Acts as substitute for affiliate RA lead as appropriate
as Drug Safety Officer (DSO) Backup Czech Republic & Slovakia
- This role is responsible to manage assigned affiliate PV tasks and responsibilities to ensure business continuity in accordance with applicable company standards, timelines and PV-related regulations / guidelines.
- On an ongoing basis, the DSO Backup supports the DSO with Quality Control (e.g., for accuracy and completeness of translations from local language and transcription of product safety information). As needed, the DSO Backup provides support during audits and regulatory authority inspections.
and Essential Job Responsibilities:
During absence of the DSO:
- Manage and ensure 24/7 availability for all PV and product safety information channels relevant to the affiliate.
- Process product safety information received from any source (i.e., solicited and unsolicited) in a timely manner, with high quality and in compliance with applicable procedures and instructions.
- Recognize and timely communicate potential safety issues to the Product Responsible Person.
- Deliver product safety awareness training in local language to new hires.
- Timely identification and communication of (potential) risks and/or quality issues.

 

Druh pracovného pomeru

plný úväzok

Požiadavky na zamestnanca

vysokoškolské II. stupňa

Miesto práce

Bratislava

Kategória

Zdravotníctvo a farmácia