Regulatory Regulatory and Pharmacovigilance Specand Pharmacovigilance Specialist (Ref. č.: 1005468)
Grafton Slovakia s.r.o.
Miesto práce:
Bratislava
Bratislava
Ponúkaný plat (základná mzda):
2 400 - 2 600 EUR
Druh pracovného pomeru:
plný úväzok
Informácie o pracovnom mieste
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.
Benefity a ďalšie výhody:
- Annual bonus - 2 sick days annually - Contributions to life and pension insurance - MultiSport card fully covered by the employer - Benefit vouchers for relaxation - Home office contribution - Extra vacation days beyond the legal requirement - Pleasant work environment and supportive team
Informácie pre uchádzača:
Zašlite nám svoj životopis v slovenskom jazyku a ak máte aj v anglickom jazyku. Viac podobných pozícií nájdete na https://www.grafton.sk/sk/job-search
Všeobecne požadované znalosti:
- At least 2 years of pharmacovigilance experience - University degree in pharmacy (or a related field) - Proficiency in basic MS Excel and Word - Fluent English (B2 level, both spoken and written) - Responsible work ethic, precision, and ability to meet deadlinesGood communication and organizational skills
Požiadavky na zamestnanca
Minimálne požadované vzdelanie:
vysokoškolské II. stupňa
Informácie o spoločnosti
Charakteristika spoločnosti:
Spoločnosť Grafton Slovakia s.r.o., svetovo uznávaný poskytovateľ personálnych služieb a sprostredkovaní práce, je personálno-poradenská agentúra so širokou pôsobnosťou. V oblasti sprostredkovania práce ponúkame stále zamestnanie, dočasné úväzky, brigády, ale tiež prácu v zahraničí. Zameriava sa predovšetkým na ponuky práce v nasledujúcich oboroch: obchod, marketing, administratíva, financie, bankovníctvo, IT, engineering, výroba, farmácia, cestovný ruch a ďalšie. Okrem ponuky práce poskytuje aj personálne poradenstvo, napr. ako napísať životopis, sprievodný list či ako sa pripraviť na pohovor.

Medzi široké portfólio Grafton služieb tiež patrí personálna inzercia na mieru, testovanie kandidátov, Assesment Centres, personálne a mzdové vedenie, konzultácie v oblasti ľudských zdrojov a Outplacement.

Graftonu záleží na kvalite, a preto sa snaží na trhu sprostredkovania práce a personálneho poradenstva ponúknuť maximálne profesionálny servis. Práve preto implementoval európsky uznávaný systém riadenia kvality ISO 9001. Certifikát ISO 9001 prispieva k snahe spoločnosti Grafton vyhovieť požiadavkám jej zákazníkov v najlepšej možnej kvalite. Ku každému zákazníkovi pristupuje individuálne s prioritou nájsť spoločné riešenie.
Pozícia / odvetvie:Zdravotníctvo a farmácia
Dátum zverejnenia:13.08.2026
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