Priyanka M.
Senior Manager, Quality Standards and Compliance (Qsc), Global Patient Safety & Risk Management @Alnylam Pharmaceuticals
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WORK HISTORY
Senior Manager, Quality Standards and Compliance (Qsc), Global Patient Safety & Risk Management @Alnylam Pharmaceuticals
US
Support development, implementation, and oversight of quality & compliance activities in support of GPS which include, but are not limited to the following:• Responsible for oversight and maintenance of the PSMF• Leads PV audit activities on behalf of QSC and GPSRM• Leads PV inspections readiness activities on behalf of QSC and GPSRM• Acts as a key point of contact between PV Quality Assurance and GPSRM to ensure collaboration between the departments.• Tracks and monitors quality system KPIs / QPIs to conduct analysis for Alnylam’s GPSRM Organization• Develops and reports pharmacovigilance compliance metrics related to GPSRM activities to ensure appropriate levels of operational performance & compliance• Independently facilitates the development, documentation, monitoring, and follow up of corrective and preventive actions related to PV activities to address compliance risks and ensure timely closure.• Authors, reviews and/or approves content for Policies, Standard Operating Procedures, Work Instructions, etc, as needed and/or requested.• Independently facilitates the development and implementation of measures to manage compliance and oversight of external groups, vendors and affiliates that impact GPS deliverables (contractual partners, vendors, client groups, CROs, etc.)• Works proactively with cross-functional teams to advance quality and compliance activities relating to PV.• Coaches and mentors staff on quality and compliance principles related to PV
EDUCATION
Northeastern University
Master's degree, Project Management
NTR University of Health Sciences
Bachelor's degree, Registered Nursing/Registered Nurse
ABOUT PRIYANKA M.
An experienced healthcare professional with a strong background in Pharmacovigilance & Project management with a passion for the safety of patients both in drug development / post-marketing use. Experienced in Risk Management, Quality assurance, & Managing troubled projects.
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