Stufenplanbeauftragter, Sr Manager – Pharmacovigilance Local Contact

This is a fully remote position, open to applicants in Germany.

📋 Description

• Oversee pharmacovigilance activities at the country level across Germany, Austria, and Switzerland, integrated within the EU and global pharmacovigilance framework.

• Act as the Stufenplanbeauftragter for Germany under Section 63a AMG when required.

• Serve as the main pharmacovigilance contact for Austria.

• Take on the responsibilities of the Swiss Responsible Person for Pharmacovigilance when officially designated.

• Monitor, evaluate, and escalate risks associated with medicinal products and ensure compliance with German-specific pharmacovigilance standards.

• Coordinate safety reporting, local pharmacovigilance obligations, risk-minimization efforts, and engagements with relevant authorities.

• Supervise safety reporting in Switzerland and liaise with Swissmedic as appropriate.

• Gather, document, reconcile, and escalate adverse events, safety data, and product-quality complaints that may pose safety concerns.

• Collaborate on safety-related initiatives with the EU Qualified Person for Pharmacovigilance (QPPV), Drug Safety, Quality Assurance, Regulatory Affairs, Medical Affairs, affiliates, and external partners.

• Ensure the local pharmacovigilance procedures, agreements, oversight of third parties, and inspection-ready records are in alignment with the global pharmacovigilance system.

• Assist with pharmacovigilance inspections, audits, regulatory inquiries, Corrective and Preventive Actions (CAPAs), and local literature monitoring.

• Support pharmacovigilance training, track regulatory developments, manage escalations, and oversee business continuity plans.

• Act as the primary local pharmacovigilance representative for designated territories and provide backup support to pharmacovigilance Network Contact Persons (NCPs) in other assigned countries.

• Contribute to strategic and operational pharmacovigilance projects and continuous enhancement initiatives that align with global pharmacovigilance goals.

⛳️ Requirements

• A degree in medicine, pharmacy, life sciences, or a related scientific field, or an equivalent combination of education, training, and relevant experience.

• Approximately 8+ years of increasingly responsible experience in pharmacovigilance, drug safety, quality assurance, or related pharmaceutical roles.

• In-depth understanding of German pharmacovigilance regulations, including Section 63a AMG, as well as EU pharmacovigilance legislation and Good Pharmacovigilance Practices (GVP).

• Familiarity with applicable pharmacovigilance requirements in Austria and Switzerland.

• Experience operating within a pharmaceutical pharmacovigilance quality framework.

• Proven experience with interactions with regulatory authorities, pharmacovigilance inspections or audits, safety inquiries, product-quality investigations, and risk management activities.

• Capability to evaluate and escalate safety risks, work collaboratively across functions, and communicate effectively in time-sensitive situations.

• Fluent in both written and spoken German and English.

• Must reside in Germany.

• Legal authorization to work in Germany.

🏝️ Benefits

• Gross annual salary range of €112,000–€140,000.

• Commitment to equal pay and pay equity practices.

• Objective, gender-neutral criteria for compensation.

• Fair and transparent remuneration practices.