SHYAM BIHADE
Pune
Summary
Post-graduate in Pharma with 9.5 years of clinical research experience, currently
serving as Feasibility Specialist at Fortrea, India. Expertise in an individual
contributor work on Disease & pathway specific market analysis, strategic planning,
benchmarking & competitive intelligence, feasibility analysis, study/site - metrics,
enrollment modeling, site/investigatorn-identification, affiliations, tiering, contact
tracing, case processing, quality review and regulatory submissions, with
comprehensive knowledge of clinical trials (Phase 1 to 4) and ICH-GCP guidelines.
Recognized as Subject Matter Expert for Canadian Regulatory Submission, ensuring
compliance and effective communication with local safety officers. Proven ability to
manage data accuracy and completeness, mentor new team members, and lead
internal meetings to enhance team performance.
Overview
11
11
years of professional experience
Work History
Senior Site Selection Specialist
Fortrea (Formerly Labcorp)
Pune, Maharashtra
06.2025 - Current
- As an individual contributor work on Disease & pathway specific market analysis, strategic planning, benchmarking & competitive intelligence, feasibility analysis, study/site - metrics, enrollment modeling, site/investigator - identification, affiliations, tiering, contact tracing. Full/Partial ownership of the Feasibility/Site identification tasks in designated lead studies inclusive of but not limited to maintaining the site ID tools, running inconsistency checks, archiving emails at regular intervals.
- Provide support to Site selection lead in their assigned tasks of site list development by performing inspection checks, past-experience checks, Citeline data extraction as requested and setting up of site ID tracker.
- Create electronic surveys using company software that is not limited to study specific surveys and hoc electronic survey requests.
- Perform review of various tasks and provide feedback to site selection specialist inclusive of but not limited to electronic surveys, site ID tool builds, Inspection check and Citeline data extraction and provide feedback.
- Maintain master site list for allocated client/indication.
- Responsible for setting up and conducting feasibility/site identification studies according to timeline and quality standards and client expectations.
- Supporting Investigator/ Site Intelligence database development and maintenance.
Lead Safety Science Specialist
Fortrea (Formerly Labcorp)
Pune, Maharashtra
10.2020 - 05.2025
- Responsible for post market reporting of ICH E2B cases
- Responsible for Clinical trial ADR reporting to regulatory agencies.
- Responsible for various formats of ICSR reporting that are submitted to Regulatory authorities, like xml format, E2B gateway reporting and transmission.
- Responsible for portal submissions, courier and manual email submissions of CIOMS, MEDWATCH.
- Responsible for prioritization of assignments to ensure that submissions are occurring within regulatory and business partner timelines.
- Responsible to ensure compliance with Health Canada regulations, guidelines (such as Food and Drugs Act, Medical Devices Regulations), and relevant ICH guidelines.
- Responsible to maintain up-to-date knowledge of regulatory requirements and changes to Health Canada regulations, providing internal teams with guidance on regulatory expectations.
- Responsible for reviewing labeling and product information, to ensure regulatory compliance.
- Responsible for reconciliation of report from Canada vigilance database.
- Responsible for late case tracking, preparation of submission metrics and performing the quality checks as applicable.
- Monitor and facilitate ICSR failed submissions.
- Ability to work well with other colleagues and functions within the organization.
- Self-motivated and target oriented.
- Excellent written and verbal communication and interpersonal skills.
- Ability to produce quality materials within tight timeframes, willingness to work in a flexible schedule.
Safety Data Analyst Patient Safety Solutions
Covance (Formerly Sciformix)
Pune, Maharashtra
06.2019 - 09.2020
- Implement consistent, efficient and quality processes to meet timelines and deliverables according triaged and classified ICSRs for report type, seriousness, causality, labeling and reporting; prioritize.
- ICSR according to regulatory requirements.
- Completed remaining case data entry, including narrative or auto-narrative.
- Completed risk and quality (label, approval, and manual coding).
- Clarified unclear or illegible information from the ICSR sender (i.e. local safety officer [LSO] or Call Center).
- Liaised with appropriate stakeholders (e.g. Global Medical Safety Operations. Physicians [GMSOP], LabCorp Pharmacovigilance Physicians [PVPs]) to clarify appropriate information required for case processing.
- Participated in project teams to improve ICSR quality.
- Documented the quality review results and provide feedback to relevant team members. Identify trends in errors and help identify training needs.
Junior Safety Data Analyst Patient Safety Solutions
Sciformix Technologies Private Limited
Pune, Maharashtra
12.2016 - 05.2019
- Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.
- Ensure compliance with operations governing regulatory requirements.
- Create, maintain and assume accountability for a culture of high customer service operational.
Senior process associate
Tata Consultancy Services
Pune, Maharashtra
06.2015 - 11.2016
- Thorough knowledge of ARISG safety databases for documentation and reporting of Adverse Events.
- Identified day 0 (LRD) and various scenarios to capture day 0 or PV receipt date.
- Performed medical coding of Adverse Events using MedDRA.
- Performed case processing of spontaneous, NIP (non-interventional program), NIS (non-interventional program) and CT (Clinical trial) cases.
- Identified adverse events responsible for creating a SUSAR report.
- Maintained consistent quality in the cases.
Education
Master of Pharmacy - Quality Assurance Techniques
Indira College of Pharmacy
Pune, MaharashtraBachelor of Pharmacy - Pharmacy
Sinhgad Institute of Pharmacy
Pune, MaharashtraSkills
Clinical Operations
Safety Data Analyst
Pharmacovigilance
Process Enhancement
Drug Safety Management
Regulatory Compliance
Regulatory Submissions
Submission
clinical trials
Case Processing
ICH-GCP Guidelines
Drug Safety
Regulatory
Site Feasibility
Address
F 601, Silver Gardenia, Aundh - Ravet BRTS road, Ravet, Pune
Appreciation and Awards
Client Appreciation Award, 2019-12-01
Languages
English
Upper Intermediate
B2
Marathi
Proficient
C2
Hindi
Proficient
C2
Hobbies and interests
- Computing
- Photography
- Painting
Timeline
Senior Site Selection Specialist
Fortrea (Formerly Labcorp)
06.2025 - Current
Lead Safety Science Specialist
Fortrea (Formerly Labcorp)
10.2020 - 05.2025
Safety Data Analyst Patient Safety Solutions
Covance (Formerly Sciformix)
06.2019 - 09.2020
Junior Safety Data Analyst Patient Safety Solutions
Sciformix Technologies Private Limited
12.2016 - 05.2019
Senior process associate
Tata Consultancy Services
06.2015 - 11.2016
Master of Pharmacy - Quality Assurance Techniques
Indira College of Pharmacy
Bachelor of Pharmacy - Pharmacy
Sinhgad Institute of Pharmacy