Stufenplanbeauftragter, Sr Manager – Pharmacovigilance Local Contact

Cytokinetics

. Lead country-level pharmacovigilance oversight across Germany, Austria and Switzerland within the integrated EU and global PV system .

Posted 11/6/2026full-timeRemote • GermanySenior💰 €112,000 - €140,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmacovigilance oversight, including strong knowledge of German, Austrian, and Swiss PV requirements, as well as EU legislation and Good Pharmacovigilance Practices. Capable of coordinating safety reporting, regulatory interactions, and maintaining compliance within a pharmaceutical PV quality system.

Highest-signal resume keywords

Pharmacovigilance OversightGerman PV RequirementsRegulatory Authority InteractionsRisk Management ActivitiesFluent German and English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceDrug SafetyQuality AssuranceRisk AssessmentSafety ReportingRegulatory ComplianceAdverse Event DocumentationProduct-Quality InvestigationsCAPA ManagementGVP Knowledge

Soft Skills

Clear CommunicationCross-Functional CollaborationTime Management

Industry Keywords

Section 63a AMGEU PV LegislationSwissmedicPharmaceutical FunctionsInspection-Ready RecordsLocal PV ProceduresContinuous Improvement InitiativesPV TrainingLocal Literature SurveillanceBusiness-Continuity Arrangements

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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