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.
The Senior Pharmacovigilance Manager supports the EU QPPV Office in maintaining an effective Pharmacovigilance (PV) system in compliance with applicable European Union regulatory requirements, company procedures, and global PV standards. The role includes operational PV support, affiliate oversight, compliance activities, training coordination, PSMF maintenance, safety information management, and acting as a back-up for key PV functions including the Deputy EU QPPV and PV National Contact Persons (NCPs).
Key Responsibilities
EU QPPV Office Support
Support the EU QPPV Office in maintaining the EU Pharmacovigilance System in compliance with EU GVP requirements and internal procedures.
Contribute to the quarterly update and maintenance of the Pharmacovigilance System Master File (PSMF), including collection, verification, and reconciliation of required information from affiliates and functional stakeholders.
Support preparation and maintenance of PV governance documentation, metrics, and oversight activities.
Assist in inspections, audits, health authority requests, and PV readiness activities as required.
Support implementation and maintenance of PV processes, SOPs, work instructions, and quality documents.
Deputy EU QPPV / PV NCP Back-up Responsibilities
Act as designated back-up for the Deputy EU QPPV and Affiliate PV National Contact Persons, as applicable.
Ensure continuity of PV activities during planned or unplanned absences.
Support communication and coordination with affiliates, competent authorities, PV main vendors, and internal stakeholders when delegated.
PV Training
Coordinate and deliver PV training to affiliate employees, global and local vendors, distributors, and relevant service providers across the EU region.
Maintain training records and ensure compliance with training requirements.
Safety Information Management
Manage translation, reporting, reconciliation, and follow-up of safety information in accordance with regulatory timelines and company procedures.
Coordinate with affiliates and third-party providers to ensure timely submission and follow-up activities.
PV Compliance and Quality Activities
Support PV compliance monitoring activities, including metrics collection, trend analysis, and compliance reporting.
Assist affiliates with the management of PV deviations, CAPAs, and effectiveness checks.
Participate in root cause investigations and continuous improvement initiatives.
Support vendor oversight and compliance activities to PV agreements with service providers.
Contribute to preparation of internal PV audits and regulatory inspections
Cross-Functional Collaboration
Collaborate with Regulatory Affairs, Quality Assurance, Medical Affairs, and Cytokinetics affiliates to ensure PV compliance.
Support implementation of new regulatory requirements.
Participate in global and regional PV projects and initiatives as assigned.
Qualifications
Education
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or related scientific discipline required.
Experience
Minimum 10 years of experience in Pharmacovigilance within the pharmaceutical or biotechnology industry.
Experience supporting EU Pharmacovigilance systems and GVP requirements.
Experience with PSMF maintenance, PV operations and compliance activities, and affiliate oversight
Experience in developing and delivering PV training to employees and external service providers
Knowledge & Skills
Strong knowledge of European Union Pharmacovigilance regulations.
Understanding of adverse event reporting requirements and PV quality systems.
Familiarity with CAPA management, deviations, inspections, and audit processes.
Excellent organizational skills and attention to detail.
Strong communication and stakeholder management skills.
Ability to work independently and collaboratively in a global matrix environment.
Proficiency in PV databases and Microsoft Office applications.
Fluency in English, and German required; additional European languages are an advantage.
Competencies
Compliance mindset and quality orientation
Strong analytical and problem-solving skills
Ability to manage multiple priorities and deadlines
Effective training and presentation skills
Team-oriented with strong interpersonal skills
Reporting Line
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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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Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
