[Hiring] Senior Manager, Pharmacovigilance Local Contact @Cytokinetics

Role Description

Cytokinetics is seeking an experienced pharmacovigilance professional to lead country-level PV oversight across Germany, Austria, and Switzerland within our integrated EU and global PV system. The role will serve as the German Stufenplanbeauftragter (Graduated Plan Officer), act as the local PV contact for Austria, and assume Swiss Responsible Person for Pharmacovigilance responsibilities where formally designated.

Working closely with the EU QPPV and cross-functional partners, you will help ensure effective safety surveillance, regulatory compliance, and inspection readiness across the DACH region.

Key Responsibilities

• Fulfil applicable German Stufenplanbeauftragter responsibilities under Section 63a AMG, including oversight, assessment, and escalation of medicinal product risks and German-specific PV requirements.
• Act as the local pharmacovigilance contact for Austria, coordinating safety reporting, local PV requirements, risk-minimisation activities, and interactions with relevant authorities.
• Where formally designated, perform Swiss Responsible Person for Pharmacovigilance responsibilities, including oversight of Swiss safety reporting and engagement with Swissmedic.
• Ensure timely collection, documentation, reconciliation, and escalation of 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, corrective and preventive actions (CAPAs), and local literature surveillance, as applicable.
• Support PV training, monitoring of regulatory changes, and appropriate escalation and business-continuity arrangements.
• Act as the primary local pharmacovigilance representative for the assigned territories and may support or provide back-up coverage to PV NCPs in other countries.
• Contribute to strategic and operational pharmacovigilance projects, continuous improvement initiatives, and other activities supporting the company's global pharmacovigilance objectives.

Qualifications

• 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 and 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.
• Candidates must be based in Germany and have the legal right to work in Germany.

Requirements

• Legal right to work in Germany.

Benefits

• The salary range for this role is €112,000-€140,000 gross annually. Final compensation will depend on skills, experience, and internal equity considerations.
• In line with Germany equal pay regulations, we apply objective, gender-neutral criteria to determine compensation.
• We actively monitor pay equity through our annual Gender Equality Index and are committed to maintaining fair and transparent pay practices.
• In compliance with Germany pay transparency legislation, compensation for this role is based on objective criteria and is aligned with our company-wide salary register.
• We are committed to ensuring equal pay for work of equal value.