Stufenplanbeauftragter / Sr Manager, Pharmacovigilance Local Contact, DACH

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

We are 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), where required under Section 63a AMG, 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.
• The Pharmacovigilance National Contact Person for DACH will act as the primary local pharmacovigilance representative for the assigned territories and may be assigned responsibility for supporting or providing back-up coverage to PV NCPs in other countries. In addition, the individual will 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.

#LI-REMOTE

Pay Range:

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.  

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

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Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

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• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer