Local Safety Officer – Stufenplanbeauftragte

🕒 October 22

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 15%

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ProductLife Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💼 Consulting

🏥 Healthcare

💊 Pharmaceuticals

💰 GROWTH EQUITY VC on 2024-04

Consulting • Healthcare • Pharmaceuticals

ProductLife Group is a global life‑sciences consulting and outsourcing firm that pairs deep human expertise with intelligent automation to help bring therapies and health products from development to patient access. The company provides end-to-end solutions across product development (pre-clinical to approval), regulatory affairs, CMC & quality, clinical development, engineering and facility construction, market & patient access, safety and compliance, and digital & AI-enabled innovation. ProductLife Group serves biopharma, medtech and consumer health clients, operates a global network of offices covering 150+ countries, and highlights ~1,750 experts and ~10k+ submissions per year.

📋 Description

• Act as Local Safety Officer for assigned clients and maintain compliance with local PV regulations • Serve as the local pharmacovigilance contact and liaise with health authorities • Manage local safety activities, including ICSR handling, submissions, reconciliations, and literature monitoring • Maintain local PV documentation, agreements, SOPs, and PSMF-related records • Support the preparation and submission of safety reports and regulatory documents • Monitor local regulatory requirements and implement updates as needed • Collaborate with clients, affiliates, vendors, and internal teams • Support audits, inspections, and quality improvement initiatives

🎯 Requirements

• Degree in Pharmacy, Life Sciences, Medicine, Nursing, or a related field • Minimum 3 years of pharmacovigilance experience • Strong knowledge of EU and local PV regulations • Experience with safety case processing and local PV activities • Fluent German and English (written and spoken) • Excellent organizational, communication, and stakeholder-management skills • Ability to work independently in a remote, international environment

🏖️ Benefits

• International, collaborative environment • Opportunities to contribute to impactful pharmacovigilance activities • Remote work in an international environment • Career growth opportunities

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