๐ง๐ต๐ถ๐ ๐ฟ๐ผ๐น๐ฒ ๐ถ๐ ๐ณ๐ผ๐ฟ ๐ผ๐ป๐ฒ ๐ผ๐ณ ๐๐ต๐ฒ ๐ช๐ฒ๐ฒ๐ธ๐ฑ๐ฎ๐'๐ ๐ฐ๐น๐ถ๐ฒ๐ป๐๐
๐ฆ๐ฎ๐น๐ฎ๐ฟ๐ ๐ฟ๐ฎ๐ป๐ด๐ฒ: ๐ฅ๐ ๐ฒ๐ฌ๐ฌ๐ฌ๐ฌ๐ฌ - ๐ฅ๐ ๐ด๐ฌ๐ฌ๐ฌ๐ฌ๐ฌ (๐ถ๐ฒ ๐๐ก๐ฅ ๐ฒ-๐ด ๐๐ฃ๐)
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
๐๐ฒ๐ ๐ฅ๐ฒ๐๐ฝ๐ผ๐ป๐๐ถ๐ฏ๐ถ๐น๐ถ๐๐ถ๐ฒ๐
โข Drive end-to-end quality assurance of patient support workflows, ensuring compliance with internal SOPs and regulatory standards.
โข Lead pharmacovigilance activities, capturing and reporting adverse events related to oncology and specialty medicine therapies.
โข Conduct regular audits of patient support documentation and processes to identify gaps and recommend corrective actions.
โข Collaborate with clinical teams to integrate realโworld evidence into patient support strategies.
โข Develop and maintain key quality metrics, reporting on performance trends to senior leadership.
โข Facilitate crossโfunctional meetings to discuss quality risks, mitigation plans, and best practices.
โข Provide guidance on regulatory updates impacting patient support and pharmacovigilance in oncology.
โข Mentor junior staff on quality processes and adherence to industry standards.
โข Coordinate external audit activities, ensuring readiness and timely resolution of audit findings.
โข Drive continuous improvement initiatives to enhance patient safety and program effectiveness.
๐ช๐ต๐ฎ๐ ๐ ๐ฎ๐ธ๐ฒ๐ ๐ฌ๐ผ๐ ๐ฎ ๐๐ฟ๐ฒ๐ฎ๐ ๐๐ถ๐
โข 3+ years of experience in quality assurance within the pharma or healthcare sector.
โข Strong background in pharmacovigilance and adverse event reporting, preferably in oncology or specialty medicine.
โข Proven experience conducting internal or external audits and implementing corrective actions.
โข Deep understanding of regulatory frameworks such as ICH, FDA, EMA, and local authorities.
โข Excellent analytical skills with the ability to translate data into actionable insights.
โข Outstanding communication and stakeholder management abilities.
โข Demonstrated leadership skills in driving continuous quality improvement initiatives.
โข Proficiency in quality management systems and risk assessment tools.
โข Ability to work effectively in a fastโpaced, multidisciplinary environment.
โข A proactive, detailโoriented mindset with a strong commitment to patient safety.