Sajitha Reema Fernandes
Bangalore
Summary
Pharmacovigilance Lead with 10+ years of experience with practical understanding of business requirements, vendor partnerships, and ensuring compliance with global regulatory requirements. Adept at managing vendor relationships, overseeing KPIs, and optimizing outsourced processes to ensure quality and operational excellence. Expertise in risk management, CAPA, and audit readiness, with a proven ability to influence stakeholders and lead high-performing teams. Strong background in training, team development, and process improvement with a focus on safety database management and global vendor governance. Seasoned Operation Specialist with practical understanding of business requirements.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Sr PV Operation Specialist (PV Lead)
GlaxoSmithKline
Bangalore
02.2021 - Current
- Lead vendor oversight and governance for safety-related services, ensuring adherence to quality and compliance metrics.
- Establish and modify KPIs for vendor performance evaluation, ensuring alignment with business objectives.
- Identify opportunities to optimize vendor support and minimize costs.
- Propose new ideas for global implementation and contribute to improving Safety processes.
- Collaborate with global stakeholders, including Local Safety Units (LSUs) and external vendors to align safety processes with global standards.
- Enhanced PV processes through automation and optimization of workflows.
- Assisted with implementing BOT processes for ICSR management and optimized the Reportum Tool for AE reporting.
- Provide subject matter expertise (SME) for audits and inspections, ensuring corrective actions align with quality requirements.
- Lead CAPA implementation and risk mitigation for vendor-managed activities.
- Manage all aspects, from case receipt to expedited reporting for all case types.
- Collaborate with SERM, local operating companies (LOCs), and clinical operations to ensure accurate documentation and processes for safety data recording and reporting.
- SME activities: Provide expert knowledge and guidance on specific subjects related to case management and safety processes for spontaneous, Clinical Trial, Literature Reports.
- Facilitate trainings, knowledge sharing sessions for vendors, Quality Assurance/Management Monitoring team as well as within the team.
- Subject Matter Expert in Argus database, spontaneous case processing, Intake and Triage, Outgoing follow up, medical devices and product Quality complaint.
- Audits and Inspections: subject matter expert (SME) and primary point of contact during audits and inspections conducted by multiple regulatory authorities, ensuring compliance and providing expert guidance.
- Process Expert: Review SMPs, study configuration requests and protocols for clinical trials, Oversee Eudravigilance downloads, local literature search, clinical trials and spontaneous ICSRs.
- Facilitate responses to Regulatory Authority queries.
- New Hire Onboarding: Train new employees to ensure they understand their roles and responsibilities, and can perform efficiently.
Operation Specialist II
IQVIA
Bangalore
01.2013 - 02.2021
- Obtain and process adverse event data obtained in clinical trials and/or post-marketing projects for both vaccines and pharma products according to applicable regulations and guidelines.
- Workflow management to ensure timely compliance with regulatory authorities and other destinations.
- Addressing queries, engaging in client meetings, conducting central training sessions, analyzing and mitigating error trends, reiterating learnings, mentoring new hires, and facilitating fun learning activities.
- Process SME for various topics (outgoing follow-up, quality review, spontaneous case processing).
Customer Service Representative
Accenture
Bangalore
10.2010 - 01.2012
- Developed customer service scripts that improved customer service representatives' ability to handle customer inquiries.
- Resolved customer complaints in a timely and professional manner, resulting in increase in customer satisfaction ratings.
- Maintained customer records and created detailed reports for management.
Education
PG Diploma - Clinical Research
Avigna Clinical Research Institute
Bangalore, India01.2012
Bachelor of Science - Nursing
Government College of Nursing
Bangalore, India01.2010
Skills
- Vendor Oversight and Governance
- KPI development and Monitoring
- Regulatory Compliance & Audit Readiness
- Process Optimization
- Cross-Functional Collaboration
- Safety System Expertise (Argus, ArisG, Reportum, Veeva)
- CAPA & RCA Management
- Analytical Thinking & Problem Solving
- Strong Written & Verbal Communication
- Detail-Oriented with Quality Focus
- Time Management & Prioritization Under Pressure
- Adaptive, Collaborative & Self-Motivated
- Onboarding and Training
Certification
PG Diploma in Clinical Research
Accomplishments
- Led a successful transition from one vendor to another in 2023, ensuring seamless process continuity.
- AHEAD Together award (2022 and 2024)
- Developed and implemented a method to improve case quality of pregnancy exposure cases, 2020
- Developed an interactive model as an initiative for kinesthetic learning, 2020
- Best employee of the quarter, 2016
Languages
- English, Fluent
- Hindi, Fluent
- Kannada, Fluent
Projects
Reportum Project, Seamless Automated HSI Collection Tool, 2024
Outbound Follow up Project, Project lead on enhancing the Outbound follow up process, 2024-2025
Single vendor Project, Successful transition from one vendor to another, 2023
Personal Information
- Date of Birth: 01/08/88
- Gender: Female
- Nationality: Indian
System And Applications
- Microsoft Office
- Argus
- ArisG
- Sceptre
- Reportum
- Veeva
- Inform
- Visio
- Copilot
- One Note
- Power BI Query and Dashboard
- Excel Basics for data analysisTECHNICAL
- Alteryx- Beginnner
Timeline
Sr PV Operation Specialist (PV Lead)
GlaxoSmithKline
02.2021 - Current
Operation Specialist II
IQVIA
01.2013 - 02.2021
Customer Service Representative
Accenture
10.2010 - 01.2012
PG Diploma - Clinical Research
Avigna Clinical Research Institute
Bachelor of Science - Nursing
Government College of Nursing
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