Beschreibung
Sie haben erste Erfahrungen im Bereich Drug Safety bzw. Pharmakovogilanz gesammelt und suchen den Sprung zu einem namhaften Biotechnologieunternehmen? Dann sind Sie genau der/ die Richtige für folgende, die ich im Augenblick betreue:Drug Saftey/ Pharmacovigilance Associate (gn) - Homebased
Your Responsibilities:
- Ability to develop a sound knowledge PV organization globally and locally and applicable procedural documents.
- Maintains up to date information on marketed status of products in the local country.
- Manages all aspects of local ICSR management:
- Collecting, recording, processing, translating and submitting adverse events (AEs) and special situation reports (SSRs) from all sources GLPS, including reports from local literature, websites and solicited programmes, in compliance with corporate requirements and local regulations.
- Conducting appropriate and timely follow-up on all ICSRs, including use of targeted questionnaires.
- Screening of local literature (where not covered in the global search) for Adverse Drug Reactions (ADRs), SSRs or other relevant safety data on a weekly basis or according to journal publications, incl. documentation.
- Recording and maintaining ICSR data (including the management of follow-up) in the Local Affiliate Module of the global safety database (LAM), including performing applicable quality checks of local cases before routing.
- Ensuring that appropriate ICSRs are notified to the local Regulatory Authority in a timely manner and in accordance with corporate and regulatory requirements where applicable, and recorded in LAM.
- Ensures archiving of safety data in accordance with the retention policy and national requirements.
- Assists the PRP locally regarding reconciliation and quality check activities including respective documentation, e.g. G360 check as applicable, Med Info non-AE Check, monthly global compliance reports, reconciliation re local projects and associated reports etc., other quality checks as applicable.
Your Requirements:
- University degree in a relevant academic field preferably in life-science, pharmacy or medicine
- At least 1 years of professional experience in the area of natural sciences and professional experience of at least one year in the field of pharmacovigilance
- Experience in working with Argus Database, MedDRA and Pharmacovigilance Regulations
- Ability to present safety data in a concise and intelligible manner
- Proven track record in time management and well-developed organizational skills
- Computer literacy and solid command of English/German, both written and spoken
- Dedication, enthusiasm, team spirit and a strong focus on quality
Haben Sie Interesse an dieser Stelle? Dann freue ich mich auf Ihre Bewerbung und ein interessantes Gespräch mit Ihnen.
Herzliche Grüße,
Stefan Blöchl
Tags: Medical, drug Saftey, Argus, Clinial, Pharmakovogilanz, Pharmacovigilance, pharma, biotechnologie
Dieser Geschäftszweig der SThree GmbH betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.