Job Summary
The Senior Pharmacovigilance Operations Manager is responsible for overseeing and managing operations within the drug safety department. This role involves hands-on involvement in ensuring compliance and safeguarding patient health through effective monitoring and reporting of adverse events.
Responsibilities
- Lead and manage pharmacovigilance operations to ensure effective risk management and safety monitoring.
- Collaborate with cross-functional teams to streamline processes and enhance operational efficiency.
- Oversee the preparation of safety reports and ensure timely submission to regulatory authorities.
- Develop and implement policies and procedures to comply with industry standards and regulatory requirements.
- Train and mentor junior staff, fostering a culture of excellence in pharmacovigilance practices.
Qualifications
- Advanced degree in life sciences, pharmacy, nursing, medicine, or a related healthcare/scientific field.
- Extensive experience in pharmacovigilance or drug safety operations management.
- Strong understanding of regulatory requirements and industry standards related to drug safety.
- Excellent leadership, communication, and interpersonal skills.
- Proven ability to manage multiple projects effectively under pressure.
Cytokinetics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
