Sunil Muktineni
Chicago,IL
Overview
13
13
years of professional experience
Work History
Associate Director Physician
AstraZeneca Pharmaceuticals
05.2022 - 09.2022
- Evaluated and integrated data from various sources, including clinical, non-clinical, and real-world data, to comprehend and manage safety signals for the COVID-19 Vaccine product
- Medical Safety Lead for aggregate safety reports and strategic documents
- Accountable for Risk Strategy, Risk Assessment, and Risk Minimization for the COVID-19 Vaccine product
- Made significant contributions to safety data queries and Health authority responses
- Supported Safety Management Team (SMT) activities, including evaluating safety issues to characterize any emerging or known product safety profiles, preparing ad-hoc regulatory reports, interpretation of surveillance and product quality data
- Functioned as a trusted partner to R&D department, representing the viewpoint on product safety, and led in a matrix environment through scientific expertise and organizational influence and impact.
Global Safety Scientist
Takeda Pharmaceutical Company Limited
04.2020 - 04.2022
- Evaluated safety data in clinical trials, study protocols, IBs, statistical analysis plans, and clinical study report documents
- Reviewed adverse events (AEs) / serious adverse events (SAEs) from clinical trials and prepared AOSE reports for IND SUSAR submission to the FDA
- Assessed standard design tables, figures, and listings of safety data from clinical studies and actively participated in study team meetings
- Authored safety sections for aggregate reports such as PSURs, PBRERs, PADERs, ACOs and DSURs, ensuring the content's quality, accuracy, completeness, and meaningful scientific/medical analysis
- Responsible for signal detection, evaluation, and management; performed data analysis to evaluate safety signals and authored analysis results for Safety Assessment Reports in collaboration with the Global Safety Physician
- Took a lead role in supporting risk management activities for assigned products, which involved preparing Risk Management Plans (RMP) and implementing risk management strategies in collaboration with cross-functional teams
- Supported ad hoc regulatory safety requests by obtaining data from the global safety database as well as literature, and assisted the Global Safety Physician in determining the impact of newly identified safety issues on the product’s benefit/risk profile
- Drafted health authority responses and PRAC responses in collaboration with the Global Safety Physician
- As the organizer and presenter, I conducted Safety Management Team (SMT) meetings regularly for the assigned products, ensuring that actionable items were completed within defined timelines, and I was responsible for preparing slides, documenting, distributing, and archiving meeting minutes.
Risk Management Lead
Shire Pharmaceuticals
10.2018 - 10.2019
- Managed a portfolio of products associated with risk management
- Authored risk management documents, including Development Risk Management Plans (DRMPs), Core RMPs, and EU RMPs, alongside Pharmacovigilance planning aligned with regulatory mandates
- Supported the Global Safety Lead (GSL) in devising risk management strategies, evaluating the necessity for risk minimizing measures, and overseeing the benefit-risk profile of the products
- Monitored risk minimization activities, which involved tracking, implementing, and assessing metrics to gauge the effectiveness of risk reduction measures for the pertinent products at local and regional levels.
Medical Reviewer
Ashfield Pharmacovigilance
02.2018 - 08.2018
- Performed safety assessments to analyze the causality, expectedness, and seriousness of individual case safety reports for designated products (both clinical trials and post-marketing), and approved the expedited submission of serious cases (including SUSARs, Fatal, and Life-threatening cases) to Health authorities
- Engaged in safety surveillance activities for clinical studies, involving the review of medical histories, medications, vital signs, and interpretation of lab results to communicate significant findings with the study lead
- Responsible for conducting in-house reviews of case report forms (CRFs), resolving queries, and ensuring the quality analysis of data listings
- Assessed all serious reports for potential signals that might necessitate a modification to the current safety profile of the product
- Offered scientific and medical insights for analyzing reported adverse events and facilitated collaboration with Medical Affairs, Clinical Development, and Regulatory Affairs to complete regulatory documentation submissions for the FDA
- Responsible for reviewing and updating protocols, investigator brochures (IBs) upon amendments, drafting summary of clinical safety reports, and preparing IND annual safety reports
- Reviewed relevant published medical literature articles concerning my assigned products to identify potential cases.
Assistant Professor, General Surgeon
NRI Medical College & Research Hospital
06.2009 - 12.2014
- 7+ years of experience as a General Surgeon
- Performed over 800 surgical procedures, emergency & elective cases
- Assisted Onco-Surgeons in evaluating cancer patients and performing surgical oncology procedures
- Teaching experience as an Assistant Professor for medical graduates
- Active participation in academic case presentations and discussions
- Mentored resident doctors and guided in their research and Thesis submissions
- Coordinated with specialty departments to achieve better therapeutic outcomes for cancer patients
- Conducted mortality meetings for critical analysis and enhancement of quality healthcare services
- During Community Medicine rotations and practical, performed various trials such as: randomized, case-control, and cohort studies
- Publication: 'Persistent Mullerian Duct Syndrome: a case report' - Indian Journal of Surgery
- Published online: 01/27/2013.
Education
M.S., (Master of Surgery) – General Surgery -
B.L.D.E. A’s Sri B.M Patel Medical College & Hospital
M.B.B.S., (Bachelor of Medicine, Bachelor of Surgery) -
M.I.M.S.R. Medical College & Hospital
Skills
- Analytical Thinking
- Team Collaboration and Leadership
- Process Improvement
- Key relationship management
- Critical Thinking
- Product Management
- Regulatory Compliance
- Data Analysis
- Risk Analysis
- Problem Resolution
Timeline
Associate Director Physician
AstraZeneca Pharmaceuticals
05.2022 - 09.2022
Global Safety Scientist
Takeda Pharmaceutical Company Limited
04.2020 - 04.2022
Risk Management Lead
Shire Pharmaceuticals
10.2018 - 10.2019
Medical Reviewer
Ashfield Pharmacovigilance
02.2018 - 08.2018
Assistant Professor, General Surgeon
NRI Medical College & Research Hospital
06.2009 - 12.2014
M.S., (Master of Surgery) – General Surgery -
B.L.D.E. A’s Sri B.M Patel Medical College & Hospital
M.B.B.S., (Bachelor of Medicine, Bachelor of Surgery) -
M.I.M.S.R. Medical College & Hospital
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