Experience

Zany Consulting Group

• Canada
• Staffing and Recruiting
• 1 - 100 Employee

• Regional Human Resources Business Partner

  • Oct 2022 - Present

  HR Business partner for North America HR Business partner for North America



Zany Consulting Group

• Regional Human Resources Business Partner

  • Oct 2022 - Present



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Learning and Development Manager

  • Jun 2021 - Oct 2022

  • Partner with site business partners to support training and compliance. • Collaborate with Toronto site Quality, Sterility Assurance, and Learning & Development departments and the technical training leaders at other sites for the management of core technical training for compliance (e.g Quality, GMP, Sterility Assurance). • Manage the technical training program for Industrial Affairs (IA) Canada that supports and contributes to support Sanofi Pasteur Global Quality Academy Community overall training strategy and objectives. • Assist in development of key technical training programs and align to site technical programs, including Sterility Assurance • Oversee the implementation of the technical training programs including coordination of logistics, SMEs, trainers and other resources and requirements. • Responsible for delivery of key technical training courses including Sterility Assurance and other Global quality programs and align with site training programs to ensure effectiveness and efficiency. • Track site technical training programs to assure compliance with regulatory requirements and internal policies. • In collaboration with key partners, develop the annual Site Quality Training Plan and oversee the Site Quality Plan deliverables for Education. • Work with training leaders at other Sanofi sites and the site Sterility Assurance, Quality and Learning and Development departments to implement training programs to continuously improve training effectiveness, standardize and harmonize training, design and develop consistent programs to align with Sanofi strategy and global best practices. • Develop & implement measurement criteria, to assess effectiveness of training, and report compliance metrics to both site and divisional levels for technical training programs. • Manage technical training project plans and all associated records according to site procedures. • Lead the design and delivery of training to support training compliance. Show less



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Document Specialist and Quality Systems Analyst, Process Excellence and Research Compliance

  • Apr 2020 - Jun 2021

  • Support the Process Excellence and Research Compliance (PERC) initiatives in records management, Standard Operating Procedure (SOP) administration, tracking for audit/inspection related requests, tracking of key compliance metrics initiatives and operational tasks relating to Medical Affairs study activities and other activities as required to support the quality initiatives for the Medical Affairs organization in accordance with ICH GCP, Company and Regulatory Authority requirements. • Manage study documents as required for Medical Affairs owned studies for all phases of the project (planning, initiation, monitoring, data management and reporting) • Filing of study documents in TMF in accordance with SOPs • Performing quality checks of the filing/metadata for TMF documents • Generate TMF status reports on a regular basis • Using a study training matrix, maintain study specific training documentation for the studies and escalate non-compliance • Super User for Clinical Systems in Canada • Maintain PERC platforms and publication tracking platforms. • Manage the life cycle of procedural documents in MA by coordinating the creation, review, approvals, periodic reviews, effective dates and obsolescence of documents using the electronic procedural document management system. • Manage all procedural document communications to applicable groups and update procedural documents related platforms • Support quality issue investigations, corrective actions and effectiveness check initiatives as required • Maintains logs and dashboards for reporting of research related data from Research tracking systems, Publication Plan tracking log and document management systems • Develops, tracks and trends compliance and research-related metrics, and work in collaboration with Subject Matter Experts (SME) to prepare dashboard metrics for communication to senior leadership and cross-functional business partners • Provide support for audits/inspections as needed Show less



FRESENIUS KABI, Canada

• Biomedical Client Services Representative

  • May 2019 - Mar 2020

  • Responsible for the coordination of Services for IV Therapy, Medical Supply, and Enteral Nutrition clients • Coordinates and prioritizes medical and I.V. supply orders by date and time for homecare patients • Coordinate timely delivery to patients and assist with resolving product and servicing issues • Demonstrate the ability to be sensitive to patient circumstances, investigative skills to resolve distribution oddities, and the ability to provide clear communication. • Member of the Joint Health and Safety Committee • Entry of equipment pick-up orders and appropriate scheduling of equipment pickups on the in-house computer system ensuring accuracy and completeness of required information to facilitate the order. • Daily interaction with patients, Nurses, and care co-ordinators at the LHIN. • Generate various reports on equipment levels and submit to the LHIN representative • Work with pharmacy and equipment department on coordinating equipment retrieval and pickup • Maintain knowledge of all company policies and procedures with high emphasis placed on ethical conduct and strict confidentiality of client information. • Adherence to corporate, regulatory and individual responsibilities supporting the Company’s quality management programs, supporting policies, procedures, work instructions • Adherence to the Company’s commitment to and policy on Patient Safety and Code of Conduct • Adherence to organizational and individual health and safety responsibilities in the workplace Show less



Cliantha Research Limited

• India
• Research Services
• 700 & Above Employee

• Clinical Research Assistant

  • Apr 2018 - Aug 2019

  • Perform clinical and study procedures as per study protocol. • Participate in the selection of subjects for clinical trial through the screening process and or required during the conduct of the study. Monitor subjects during in house confinement periods for protocol and SOP requirement. • Review the protocols and reports. Collection, analysis, review and management of study data. • Adverse event reporting for submission to Health Canada. Conducting follow up activities (fax/email/telephone) as required. • Participate in development and execution of quality control process. • Review study documents for completeness and accuracy and ensure all corrections are followed up. • Active role in new hire training process. • Prepare for Audits and Inspection Readiness checks. Show less



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Drug Safety Associate

  • Jul 2018 - Sep 2018

  • Ensure that most of the safety reports that are received from the investigational sites or from the post- marketing sector must be identified & reported in accordance to the ICH-GCP standards & also by the standard operational procedures (include reports from spontaneous sources, clinical trials, marketing activities, HCPs and consumers) • Ensures that the reports collected are organized based on the seriousness or effectiveness of the drug initially. • Worked on ARGUS, ARISg • An overall consistency in assessing the adverse reaction reports must be accurate & legible. • Communicate with clinical physicians in drug safety (fax/email/telephone) as and when required and applying clinical judgement to assess case report forms • Managed Product Quality Complaints and Technical Complaints • Only member in the team to process line listing cases from Health Canada. • Evaluate and prepare adverse event reports • Participate in team discussions and provide inputs as required • Vendor training (DSSs and DSAs) and oversight (at a global level) • Prepare for Audits and Inspection Readiness checks. Show less



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager, Quality and Compliance

  • Apr 2015 - Jan 2018

  • Managing a team of 7 Global Trainers.• Lead new hire and On-Boarding trainings.• Prioritize needs analysis to identify role based training gaps and co-ordinate with the SMEs to address the causative factors.• Develop training effectiveness metrics and perform trend analysis.• Ensure learning objectives are achieved well according to compliance requirements. • Liaise with the client Quality and Compliance team to check for completeness, consistency and accuracy of information captured in the regulatory databases. • Responsible for preparation and maintenance of SOPs/WIs etc.• Prepare for Audits and Inspection Readiness checks.• Constantly strive to maintain strong interpersonal relationships within multiple teams. Show less

• Global Trainer, Global Trainings and Document Control (Regulatory Affairs)

  • Apr 2014 - Mar 2015

  • Train regulatory professionals across the world over diverse business processes involved in Regulatory Affairs/Industrial Affairs/Quality and Compliance. These trainings included a basic curriculum for new hires and were also customized according to the business needs of the individuals involved at various hierarchical positions. • Subject Matter Expert for development of relevant training material required for self-study/classroom training/e-learning.• Manage training request platform.• Collaborate cross functionally with SMEs from Regulatory & Medical Affairs and organize live meetings (on-site/off-site) to create/review/update the training material. • Manage the Access Control System to ensure regulated, limited and guided access to the client regulatory databases and electronic tools for well-deserved users only. • Maintain client’s regulatory databases (for activities like data remediation/data cleaning/data extraction/data migration etc.) • Participate in meetings with the external and internal stakeholders. Show less

• Pharmacovigilance Scientist (Drug Safety Associate)

  • Oct 2012 - Mar 2014

  • Process Individual Case Safety Reports (ICSRs) and non-case reports in AWARE.• Possess working knowledge of the adverse event (AE) safety profile of assigned drugs/class of drugs, Reference Safety Information documents, data entry conventions and guidelines. • Narrative writing• Maintain awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.• Work within well defined timelines- liaise with other team members to manage the workload• Prepare adverse event reports.• Follow up with clinicians as and when required• Prepared for Audits and Inspection Readiness checks. Show less