Hemang Parbat
Brampton,Canada
Summary
Experienced healthcare professional and pharmacovigilance leader with over 15 years of progressive responsibility in global drug safety, patient safety, and regulatory compliance. Proven track record of leading pharmacovigilance teams, managing Health Authority audits, and navigating complex safety and regulatory challenges. Well-versed in Canadian regulatory affairs with a strong understanding of Health Canada, ICH-GCP, and international PV regulations. Adept at stakeholder engagement, strategic safety planning, and cross-functional collaboration. Committed to fostering high-performing teams and ensuring the highest standards of patient safety and regulatory excellence.
Overview
18
18
years of professional experience
Work History
Director, Pharmacovigilance
Allucent Research Canada Inc.
12.2021 - Current
- Lead the pharmacovigilance function across multiple therapeutic areas with strategic oversight.
- Ensure compliance with Canadian and global PV regulations, including Health Canada.
- Drive process improvements, team development, and risk mitigation strategies.
- Manage pharmacovigilance operation systems budgets in collaboration with the Global Head of Pharmacovigilance
- Steer technology roadmap discussions during Steering Committee meetings and get approval.
- Implement automation (AI/ML/LLM/NLP) in process to enhance overall efficiency and quality.
- Oversee process compliance and ensure audit/inspection readiness.
- Serve as primary PV contact for audits, inspections, and client engagements.
- Oversee safety surveillance activities and regulatory submissions of ICSRs.
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Improved project efficiency with strategic planning, resource allocation, and time management practices.
Operations Specialist – Pharmacovigilance
IQVIA Canada
04.2021 - 12.2021
- Lead pharmacovigilance operations in alignment with Health Canada regulations and global compliance standards.
- Oversaw ICSR processing, medical coding (MedDRA), and narrative authorship while ensuring quality and timely submissions.
- Performed quality assurance reviews and provided regulatory reportability assessments.
- Trained and mentored team members across safety services; led initiatives to enhance PV processes and implement efficiencies.
- Engage with cross-functional teams to support safety publishing, risk management, and regulatory submissions.
- Utilized advanced analytical skills in order to resolve complex operational issues effectively.
Safety and PV Specialist
Syneos Health Canada LP
02.2021 - 04.2021
- Processed and evaluated ICSRs per Canadian and international regulations, ensuring accuracy and completeness.
- Participated in expedited regulatory reporting, interdepartmental reconciliation of SAEs, and compliance oversight.
- Supported internal audits and contributed to continuous improvement in PV processes.
Drug Safety Associate – Global Pharmacovigilance
Apotex Inc., Canada
12.2019 - 01.2021
- Maintained oversight of vendor-processed ICSRs to ensure quality and compliance.
- Managed Health Canada submissions and literature surveillance activities.
- Participated in system validation for Argus upgrade and internal safety system improvements.
- Supported signal detection initiatives and collaborated with internal teams on aggregate safety reporting.
- Navigated intricacies of drug safety databases to process adverse event reports.
- Reconciled discrepancies found during adverse event data entry, resolving issues promptly while maintaining data integrity.
Senior Manager – Global PV & Signal Detection Lead
Apcer Life Sciences, India
03.2014 - 07.2019
- Led a team of safety professionals in signal detection and safety risk management.
- Direct strategy and prioritization of safety review activities, ensuring alignment with global regulatory expectations.
- Interfaced with QPPV and clients to address emerging safety signals and regulatory issues.
- Led preparation for successful MHRA and USFDA inspections with no critical findings.
- Delivered process improvements, maintained team performance dashboards, and conducted training on global PV procedures.
- Improved team performance by providing comprehensive training and fostering a collaborative work environment.
- Collaborated closely with peers from other departments to drive organizational success jointly as one cohesive unit.
- Mentored junior staff members for skill development and career progression within the organization.
Product Quality Lead
Accenture Services Pvt. Ltd., India
12.2011 - 02.2014
- Oversaw clinical trial SAE receipt and ensured compliance with project SOPs.
- Conducted medical review of adverse event reports and authored narrative summaries.
- Trained team members and maintained compliance with global PV regulations.
- Reduced customer complaints by identifying areas for improvement and initiating corrective actions.
- Communicated effectively with customers regarding their concerns or inquiries related to product quality or safety.
- Promoted teamwork and collaboration within the Quality team, leading to increased productivity and overall job satisfaction.
Associate Scientist/Clinical Investigator
GVK Biosciences Pvt. Ltd., India
01.2010 - 01.2011
Principal Investigator, BABE studies
Lambda Therapeutics Research Ltd., India
01.2007 - 01.2010
Education
M.D. - Medicine
B.J Medical College, Gujarat University
Ahmedabad, India01.2007
Skills
- Pharmacovigilance & Patient Safety Oversight
- Leadership & People Management
- Safety Signal Detection & Risk Management
- ICSR Processing & Medical Review
- Health Authority Audit Readiness (Health Canada, USFDA, MHRA)
- Regulatory Affairs & Health Canada Compliance
- Cross-functional Collaboration & Stakeholder Engagement
- Strategic Direction & Project Management
- Budget Oversight & Process Optimization
- Drug Safety Databases (ARGUS, ARISg, Empirica Trace)
- Decision-making
- Verbal and written communication
Accomplishments
- Successfully led Argus upgrade project with high-quality outcomes; recognized with 'Take a Bow' award at Apotex Inc.
- Completed backlog signal detection project for multiple clients, meeting MHRA commitments at Apcer Life Sciences.
- Faced MHRA and USFDA inspections with no critical findings at Apcer Life Sciences.
- Managed high-volume AE reporting during regulatory transitions at Apcer Life Sciences.
- Awarded 'Employee of the Year' at Accenture for exceptional performance and compliance in clinical trial case processing.
Timeline
Director, Pharmacovigilance
Allucent Research Canada Inc.
12.2021 - Current
Operations Specialist – Pharmacovigilance
IQVIA Canada
04.2021 - 12.2021
Safety and PV Specialist
Syneos Health Canada LP
02.2021 - 04.2021
Drug Safety Associate – Global Pharmacovigilance
Apotex Inc., Canada
12.2019 - 01.2021
Senior Manager – Global PV & Signal Detection Lead
Apcer Life Sciences, India
03.2014 - 07.2019
Product Quality Lead
Accenture Services Pvt. Ltd., India
12.2011 - 02.2014
Associate Scientist/Clinical Investigator
GVK Biosciences Pvt. Ltd., India
01.2010 - 01.2011
Principal Investigator, BABE studies
Lambda Therapeutics Research Ltd., India
01.2007 - 01.2010
M.D. - Medicine
B.J Medical College, Gujarat University
Similar Profiles
Sydney ROOKSSydney ROOKS
Proposals Associate II at AllucentProposals Associate II at Allucent
Abdul-Razak Bawa YussifAbdul-Razak Bawa Yussif
Statistical Assistant at Manitoba Research Data Centre, Statistics Canada / Government of CanadaStatistical Assistant at Manitoba Research Data Centre, Statistics Canada / Government of Canada
Seenivasan BSeenivasan B
Senior Network Administrator at Allucent India Pvt LtdSenior Network Administrator at Allucent India Pvt Ltd
Charbel DaherCharbel Daher
Team Lead at Paramount Fine Foods CentreTeam Lead at Paramount Fine Foods Centre
Tanvir SandalTanvir Sandal
Client Advisor at Armani ExchangeClient Advisor at Armani Exchange