Bijesh Manikoth
Mumbai
Summary
Dynamic healthcare leader with extensive experience, excelling in post-market surveillance & risk management and clinical trial safety operations. Proven track record in leading safety strategy development and optimizing stakeholder relationships. Adept at navigating regulatory compliance and driving clinical evaluations, ensuring product safety and performance excellence.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Senior Manager, Post Market Surveillance & Safety
Philips
Pune
09.2024 - Current
- Leading Precision Diagnosis (PD) Post Market Surveillance and product Safety including Complaint Handling, PMS and Risk Management
- Review post market and signal assessment data for potential product performance and safety issues.
- Drive Post Market Clinical Follow-Up (PMCF), Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) activities.
Director Safety Strategy
JNPMEDI Inc.
Seoul
10.2023 - 07.2024
- Design and oversight of PMS safety strategy and Risk management planning.
- Led safety services practice, overseeing case management, preparing aggregate safety reports, and managing signal and risk operations.
- Leading the Safety database design, product roadmap preparation and periodic launch plans (GTM strategy).
Associate Director, Drug Safety & PV
Hanmi Pharmaceuticals
Seoul
05.2021 - 04.2023
- Successfully led the Drug Safety department of 30+ scientists and physicians.
- Managed safety strategy and surveillance for 15 global clinical trials, 500+ marketed drugs, and 50+ medical devices, ensuring compliance and risk mitigation.
- Head of Safety Operations (case processing and literature monitoring), Safety surveillance (aggregate safety reports, PSURs medical devices, RMPs and signal management) and PV Systems (database management, quality document management and audits/inspection handling) teams.
- Led PV inspections (FDA, MFDS, Health Canada) and audits for 3 of Top 10 Global Pharma, ensuring adherence to regulatory standards.
Associate Manager, Safety Solutions
Indegene
Bengaluru
10.2016 - 04.2021
- QA Manager for PV Quality Assurance team for Global Top 5 Pharma for 4+ years (ICSRs, PBRERs/ DSURs/ RMPs & Signal detection).
- Managed Safety Data Exchange Agreements (SDEAs / PVAs) project for Global Top 5 Pharma, ensuring compliance and effective collaboration across stakeholders.
- Led Medical device safety narratives (CEC), CSRs, PMS Plans and PSURs team for Global top 5 Medical device company.
- SME for transformative software products using new technologies like AI / NLP / NLG and analytics including ICSR Intake automation, Aggregate report automation, Narrative automation, etc.
Quality Review Specialist
IMEDGlobal (Clinchoice)
Bengaluru
02.2015 - 10.2016
- Led quality control activities for aggregate safety reports (PSURs, PBRERs, DSURs, RMPs, PADERs) to ensure compliance and uphold safety standards for global top 5 pharma.
- Conducted quality review and trend analysis of aggregate reports prepared by global CRO, identifying key insights to support regulatory compliance.
Scientific Writing Lead
Indegene
Bengaluru
10.2013 - 01.2015
- Lead a team of Aggregate Safety Reviewers and Regulatory Labelling Associates for Global Top 2 Pharma.
- Coordinated and authored sections of CCDS, SmPC, IB, and IFUs to support regulatory submissions.
- Conducted literature review for safety signal detection.
- Evaluated signals using FDA-AERS and Vigibase to identify potential safety concerns.
PV Quality Control Officer
Accenture
Bengaluru
02.2012 - 10.2013
- Executed ICSR quality control and quality assurance activities to ensure compliance with regulatory standards.
- Conducted root cause analysis and corrective action preventive action for identified deviations to enhance process reliability.
- Facilitated refresher training on ICSR processes to reinforce team knowledge and adherence to protocols.
Drug Safety Associate
ICON
Trivandrum
08.2010 - 09.2011
- Oversaw pharmacovigilance processes for three Phase 2/3 oncology clinical trials.
- Conducted safety review of clinical data and patient labs to identify potential risks and ensure patient safety.
- Processed SUSARs, serious adverse events and spontaneously reported adverse events for Global Top 5 Pharma.
Drug Safety Associate
Accenture
Bengaluru
07.2009 - 07.2010
- Joined initial team for one of largest pharmacovigilance ICSR outsourcing deals to India, contributing to project launch and operational establishment.
- Performed triage of adverse event reports, prioritized cases, managed data basing, conducted medical/drug coding, and prepared safety narratives for regulatory compliance.
Education
Master of Science - Clinical Research
Cranfield University
United Kingdom07.2009
Bachelor of Science - Biotechnology
Bangalore University
Bangalore07.2007
Skills
- Post market surveillance
- Medical Device Safety
- Safety strategy development
- Risk Management
- Regulatory compliance
- Regulatory intelligence
- Pharmacovigilance
- Clinical evaluation
- Clinical trial operation
- Complaint handling
- Safety Database Administration
- Project Management
- Stakeholder management
- Negotiation
- Product pipeline design
Websites
Ha Inspections
- Ministry of Food and Drug Safety, South Korea (MFDS), 03/2022
- Food and Drug Administration, USA (FDA), 10/2022
- Health Canada, 06/2022
- MHRA, United Kingdom, 10/2019
- MFDS, 10/2021
- FDA, 06/2021
Conferences And Courses
- World Drug Safety Congress, Terrapinn, Delegate, 2021
- DIA Annual Conference, DIA, Delegate, 2021
- ISCR Annual Conference, ISCR, Delegate, 2018, Speaker at 2018 and 2019 annual conferences
- MHRA GCP Symposium, MHRA, 03/2022
- MHRA GPVP Symposium, MHRA, 03/2022
- Regulatory writing workshop, ISCR, 11/2019
- Data Analysis and Query Building with MedDRA, MedDRA, 01/2014
- Workshop on Standardized MedDRA Queries (SMQs), MedDRA, 01/2014
Certification
Advanced SAS Programmer.
Timeline
Senior Manager, Post Market Surveillance & Safety
Philips
09.2024 - Current
Director Safety Strategy
JNPMEDI Inc.
10.2023 - 07.2024
Associate Director, Drug Safety & PV
Hanmi Pharmaceuticals
05.2021 - 04.2023
Associate Manager, Safety Solutions
Indegene
10.2016 - 04.2021
Quality Review Specialist
IMEDGlobal (Clinchoice)
02.2015 - 10.2016
Scientific Writing Lead
Indegene
10.2013 - 01.2015
PV Quality Control Officer
Accenture
02.2012 - 10.2013
Drug Safety Associate
ICON
08.2010 - 09.2011
Drug Safety Associate
Accenture
07.2009 - 07.2010
Master of Science - Clinical Research
Cranfield University
Bachelor of Science - Biotechnology
Bangalore University