Pharmacovigilance Specialist

Have you already gained initial experience in Drug Safety or Pharmacovigilance, bring along knowledge in PV-reports from Rx-Logix and are now ready to take the next step with a leading biotechnology company? If so, you could be the ideal candidate for the following opportunity I am currently managing:

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:

• Hands-on Experience with PV-Reports as a must Have

• University degree in a relevant academic field preferably in life-science, pharmacy or medicine

• No German skills required
• 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

Are you interested in this position? I look forward to receiving your application and having an engaging conversation with you.

Best regards,

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.