Stufenplanbeauftragter / Sr Manager, Pharmacovigilance Local Contact, DACH

Kurz zusammengefasst

Cytokinetics is a specialty cardiovascular biopharmaceutical company that leverages more than 25 years of research in muscle biology to develop new medicines for cardiac muscle disorders. The firm is looking for a senior pharmacovigilance professional to act as the German Stufenplanbeauftragter, the local PV contact for Austria, and, where designated, the Swiss Responsible Person for Pharmacovigilance. The role sits within Cytokinetics' integrated EU and global PV system and works closely with the EU QPPV and cross‑functional partners to keep safety surveillance, regulatory compliance and inspection readiness on track across Germany, Austria and Switzerland. On a daily basis the incumbent will fulfil the German Stufenplanbeauftragter duties required by Section 63a AMG, overseeing risk assessment, escalation and German‑specific PV obligations. They will coordinate safety reporting and risk‑minimisation activities for Austria, and, if appointed, manage Swiss safety reporting and liaison with Swissmedic. The position also requires timely collection, documentation and reconciliation of adverse events, safety information and product‑quality complaints, as well as coordination of related actions with Drug Safety, Quality Assurance, Regulatory Affairs, Medical Affairs, affiliates and external partners. Maintaining local PV procedures, third‑party oversight and inspection‑ready records, supporting audits, inspections and regulatory inquiries, and contributing to literature surveillance and business‑continuity planning are also part of the routine. The candidate must hold a degree in medicine, pharmacy, life sciences or a comparable scientific field, or an equivalent mix of education and experience. Around eight or more years of progressively responsible experience in pharmacovigilance, drug safety, quality assurance or related pharmaceutical functions are required. A strong grasp of German PV legislation, especially Section 63a AMG, and EU GVP is essential, together with working knowledge of Austrian and Swiss requirements and experience within a pharmaceutical PV quality system. The role demands proven experience with regulatory authority interactions, PV inspections or audits, safety inquiries, product‑quality investigations and risk‑management activities. Fluency in written and spoken German and English is mandatory, and candidates must reside in Germany with the legal right to work there. Preferred attributes include the ability to assess and escalate safety risks, work effectively across functions and communicate clearly under tight deadlines. The position may involve acting as the primary local PV representative for the DACH region and providing backup support to PV contacts in other countries. In addition, the individual will be expected to take part in strategic and operational PV projects, continuous‑improvement initiatives and other activities that advance Cytokinetics' global pharmacovigilance goals. The role is offered on a remote‑friendly basis, with a salary range of €112,000‑€140,000 gross per year, determined by skills, experience and internal equity. What the role asks for: - Degree in medicine, pharmacy, life sciences or related field - Approximately 8 + years pharmacovigilance or related experience - Strong knowledge of German PV law, Section 63a AMG - Familiarity with EU GVP and Austrian & Swiss PV requirements - Experience with regulatory authority interactions and PV inspections - Ability to assess and escalate safety risks - Fluent written and spoken German - Fluent written and spoken English - Legal right to work in Germany - Nice‑to‑have: backup support for PV contacts in other countries.