Pharmacovigilance Specialist - Hombased

Pharmacovigilance Specialist - Hombased

Progressive is seeking a dedicated Pharmacovigilance Specialist – Homebased to join our team. If you have initial experience in Drug Safety or Pharmacovigilance and are ready to take the next step with a leading biotechnology company, you might be the ideal candidate.

Base pay range

Pay range is provided by Progressive. Your actual pay will be based on your skills and experience – discuss details with your recruiter.

Responsibilities

• Develop a sound knowledge of PV organization globally and locally and applicable procedural documents.
• Maintain up-to-date information on marketed status of products in the local country.
• Manage all aspects of local ICSR management.
• Collect, record, process, translate and submit adverse events (AEs) and special situation reports (SSRs) from all sources (GLPS, local literature, websites, solicited programmes) in compliance with corporate requirements and local regulations.
• Conduct appropriate and timely follow‑up on all ICSDs, including use of targeted questionnaires.
• Screen local literature (where not covered in the global search) for Adverse Drug Reactions (ADRs), SSRs or other relevant safety data weekly or as per journal publications, with documentation.
• Record and maintain ICSR data (including follow‑up management) in the Local Affiliate Module of the global safety database (LAM), performing applicable quality checks before routing.
• Notify the local Regulatory Authority of appropriate ICSDs in a timely manner, recording them in LAM, in accordance with corporate and regulatory requirements.
• Ensure archiving of safety data in accordance with the retention policy and national requirements.
• Assist the PRP locally with reconciliation and quality check activities, including documentation such as G360 checks, Med Info non‑AE checks, monthly global compliance reports, and other quality checks as applicable.

Requirements

• Hands‑on experience with PV‑Reports as a must‑have.
• University degree in a relevant academic field, preferably life‑science, pharmacy or medicine.
• No German skills required.
• Experience working with Argus Database, MedDRA, and Pharmacovigilance Regulations.
• Ability to present safety data concisely and intelligibly.
• Proven track record in time management and strong organizational skills.
• Computer literacy and solid command of English and 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