Quality SPOC Patient Support Program

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: - ( - )

Experience: 3+ yrs

Location: Bangalore, Mumbai

As a Quality SPOC Patient Support Program, you will serve as the central coordinator ensuring that all patient support initiatives meet the highest standards of quality and compliance. You will actively monitor program processes, identify potential risks, and drive continuous improvement initiatives in the oncology and specialty medicine domains. Leveraging your expertise in pharmacovigilance, you will oversee adverse event identification and reporting, ensuring timely and accurate communication to regulatory bodies. Your role will involve collaborating with cross-functional teams to align patient support activities with internal quality frameworks and external regulatory requirements. You will also provide training and mentorship to staff, fostering a culture of excellence and patient-centric care across the organization.

Requirements

• Drive end-to-end quality assurance of patient support workflows, ensuring compliance with internal SOPs and regulatory standards.
• Lead pharmacovigilance activities, capturing and reporting adverse events related to oncology and specialty medicine therapies.
• Conduct regular audits of patient support documentation and processes to identify gaps and recommend corrective actions.
• Collaborate with clinical teams to integrate real-world evidence into patient support strategies.
• Develop and maintain key quality metrics, reporting on performance trends to senior leadership.
• Facilitate cross-functional meetings to discuss quality risks, mitigation plans, and best practices.
• Provide guidance on regulatory updates impacting patient support and pharmacovigilance in oncology.
• Mentor junior staff on quality processes and adherence to industry standards.
• Coordinate external audit activities, ensuring readiness and timely resolution of audit findings.
• Drive continuous improvement initiatives to enhance patient safety and program effectiveness.
• 3+ years of experience in quality assurance within the pharma or healthcare sector.
• Strong background in pharmacovigilance and adverse event reporting, preferably in oncology or specialty medicine.
• Proven experience conducting internal or external audits and implementing corrective actions.
• Deep understanding of regulatory frameworks such as ICH, FDA, EMA, and local authorities.
• Excellent analytical skills with the ability to translate data into actionable insights.
• Outstanding communication and stakeholder management abilities.
• Demonstrated leadership skills in driving continuous quality improvement initiatives.
• Proficiency in quality management systems and risk assessment tools.
• Ability to work effectively in a fast-paced, multidisciplinary environment.
• A proactive, detail-oriented mindset with a strong commitment to patient safety.