Saritha Venkatesh
EMD Serono
Quincy,MA
1
Language
9
years of professional experience
Medical Director experienced in strategic planning, patient safety, and operational workflow enhancements. Led ICSR quality improvements and developed medical assessors to drive compliance and safety in pharmacovigilance. Managed multidisciplinary teams to improve patient outcomes while demonstrating leadership in clinical research and patient care protocol development.
Work History
Medical Director, Head of Medical Assessment Team
8 Years 7 Months- Executed tasks in rapidly changing environments, enhancing team adaptability and performance.
- Global Medical Safety Product lead for Rebif at EMD Serono: In 2016 and 2017, was the Global Medical Safety Product lead for Rebif, responsible for compliance in case processing, signal detection, authoring aggregate reports, emerging safety concerns, safety and benefit-risk assessment reports.
- Current role and leadership in Global Patient Safety (GPS) at EMD Serono: Since October 2024, served as Medical Director and Head of the Medical Assessment Team (MAT) in Global Patient Safety at, focusing on developing medical safety assessors, medical review of ICSRs in safety database and maintaining ICSR quality and compliance.
- Achieved streamlined drug safety follow-up processes through effective leadership from 2017 to 2018. Facilitated seamless product transfers and enhanced vendor team training. Delivered improved operational workflows during transition management.
- Managed comprehensive adverse event reporting processes and regulatory documentation to ensure adherence to safety standards.
- Streamlined drug safety follow-up processes from 2017 to 2018, facilitating product transfers and improving vendor team training and operational workflows during transition management.
- Executed tasks efficiently in rapidly changing environments, contributing to overall team success.
- Managed safety reporting processes for Egrifta® and conducted signal detection activities for fertility and metabolic products, ensuring compliance with FDA and international regulations.
- Proven ability to learn quickly and adapt to new situations.
Education
M.D. - Medicine And Obstetrics And Gynaecology
Skills
Medical Assessment and Causality for ICSRs
Case processing development
ICSR improvement
ICSR assessment
Case Processing Leadership
Clinical studies
Case management
Strategic planning
Strategic Partnerships
Microsoft (Powerpoint
Word and Excel)
Microsoft Excel
Medical education
Languages
English
Full Professional
Timeline
Medical Director, Head of Medical Assessment Team
EMD Serono
01.2018 - CurrentRead More
Madras Medical College
M.D. from Medicine And Obstetrics And Gynaecology
Read More
High Impact Award from Leadership
Received a high amount cash award for my innovative interaction with leadership and executive team leaders in 2024.