Stufenplanbeauftragter, Sr Manager – Pharmacovigilance Local Contact

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🔥 1 hour ago

🇩🇪 Germany – Remote

💵 €112k - €140k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Cytokinetics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1998

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $450M Post-IPO Debt on 2022-06

Healthcare • Consulting • Manufacturing

Cytokinetics is a late-stage biopharmaceutical company that focuses on the discovery, development, and commercialization of potential medicines aimed at improving muscle function. The company is particularly active in developing treatments for cardiovascular and neuromuscular diseases, such as heart failure, hypertrophic cardiomyopathy, and other conditions of impaired muscle function. Cytokinetics has a robust pipeline of small molecule muscle activators and inhibitors and is committed to improving patients' lives through its scientific research and development efforts. The company's mission revolves around empowering muscle and thereby empowering lives, with patients being the central focus of its activities. Based in South San Francisco, Cytokinetics has been pioneering the field of muscle biology for over 25 years.

📋 Description

• Lead country-level pharmacovigilance oversight across Germany, Austria and Switzerland within the integrated EU and global PV system • Serve as the German Stufenplanbeauftragter under Section 63a AMG where required • Act as the local pharmacovigilance contact for Austria • Assume Swiss Responsible Person for Pharmacovigilance responsibilities where formally designated • Oversee, assess and escalate medicinal product risks and German-specific PV requirements • Coordinate safety reporting, local PV requirements, risk-minimisation activities and interactions with relevant authorities • Oversee Swiss safety reporting and engage with Swissmedic where designated • Collect, document, reconcile and escalate adverse events, safety information and product-quality complaints with potential safety implications • Coordinate safety-related actions with the EU QPPV, Drug Safety, Quality Assurance, Regulatory Affairs, Medical Affairs, affiliates and external partners • Maintain local PV procedures, agreements, third-party oversight and inspection-ready records aligned with the global PV system • Support PV inspections, audits, regulatory inquiries, CAPAs and local literature surveillance • Support PV training, monitoring of regulatory changes, escalation and business-continuity arrangements • Serve as the primary local pharmacovigilance representative for assigned territories and provide backup coverage to PV NCPs in other countries as assigned • Contribute to strategic and operational pharmacovigilance projects and continuous improvement initiatives supporting global PV objectives

🎯 Requirements

• Degree in medicine, pharmacy, life sciences or a related scientific discipline, or an equivalent combination of education, training and relevant experience • Approximately 8+ years of progressively responsible experience in pharmacovigilance, drug safety, quality assurance or related pharmaceutical functions • Strong knowledge of German pharmacovigilance requirements, including Section 63a AMG, and EU PV legislation and Good Pharmacovigilance Practices (GVP) • Working knowledge of applicable Austrian and Swiss PV requirements • Experience operating within a pharmaceutical PV quality system • Experience with regulatory authority interactions, PV inspections or audits, safety inquiries, product-quality investigations and risk-management activities • Ability to assess and escalate safety risks, work cross-functionally and communicate clearly under time-sensitive conditions • Fluent written and spoken German and English • Must be based in Germany • Legal right to work in Germany

🏖️ Benefits

• Gross annual salary range of €112,000–€140,000 • Equal pay and pay equity practices • Objective, gender-neutral compensation criteria • Fair and transparent pay practices

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