Himanshu Patel, MSc

• Accountable for recognizing an adverse event and medical device incident regularly orginated from different patient support programs (PSPs). • Act as a contact point for the clients and work directly with internal and external stakeholders. • Conduct adverse event related trainings for pharmacists, nurses and reimbursement team. • Developed and implemented different work instructions for collection of adverse events, follow-up activities, quality check and reconciliation as per the pharmacovigilance agreements. • Improved processes for documenting deviation and CAPA to maintain the compliance standard.

• Single-handedly managed a portfolio of 30 products (CNS, Cardiac, GI, Psychiatric, Ophthalmic, Pain & Oncology) for all PV-related activities in Canada including but not limited to ICSRs management, literature and regulatory database screening, aggregate report writing (7 products), quality & compliance. • Led Health Canada inspection - 2023 (15,500 ICSRs) and client audit - 2024 (10,750 ICSRs) for the period covered 6 years and 4 years respectively. • Drafted, negotiated responsibilities and finalized 5 Pharmacovigilance Agreements (PVAs) for Europe and United State based clients. • Finalized and submitted addendum risk management plans for antibiotics with reference to respective European RMPs to Health Canada. • Improved processes for screening & notifying to Health Canada of foreign actions, social media screening, PV-deviation and CAPA, management of late ICSRs and established KPIs for compliance monitoring. • Created new SOPs for screening & notifying to Health Canada of foreign actions, social media screening and updated other PV-related SOPs to align the process more with regulatory and clients’ requirements. • Implemented new work instructions (WIs) guidelines for literature and Canada Vigilance Database (CVD) screening, ICSRs causality assessment methods and process, ICSRs workflow for different partners and quality metrics to meet the compliance target. • Performed monthly reconciliation and compliance activities with partners to maintain regulatory standard and clients expectations. • SME in internal PV audit to identify improvement areas and conducted internal PV trainings for new and existing staff, as required. • Additional regulatory responsibilities – Supported regulatory team for RSI update, complied medical and scientific information to complete FRM-0522 (exceptional import and sale) and FRM-0378 (medical necessity) forms requested by Health Canada. • Responded to medical inquires received from Healthcare Professionals and patients.

• Recorded ICSRs in Argus according to regulations, guidelines, SOPs and keep track in accordance with customer requirements to ensure stringent corporate and regulatory compliance. • Performed all the Pharmacovigilance activities as per client requirements and reviewed data against source documents of cases and submission of the reports. • Ensured self-training of SOPs, Work Instructions, global drug and device regulations, ICH guidelines, Good Pharmacovigilance Practice modules and the drug development process. • Assisted the team with follow-up process to the healthcare professionals, analyzing CAPA for regulatory late cases and daily workflow distribution.

• People management in preparation of blister packs using automated machinery and high-tech. equipment for delivery to pharmacies throughout Ontario and conducted comprehensive quality checks of packages.

• Conducted reconciliation with internal departments and expedited case determination to expertly generate query for non-valid ICSRs within just one business day of receipt as per client standard operating procedures (SOPs). • Monitored compliance standards and targets with regards to reporting timelines, quality of reporting, and queries from stakeholders and manufacturers and prepared Safety Management Plan. • Responsible for accurate and completeness of Pharmacovigilance information as per client’s conventions including audit preparation and electronic filing of PV documents to maintain audit readiness at all times. • Participated in internal audits and implemented efficient quality processes to meet regulatory timelines and deliverables according to the requirements of client’s SOP.

• Processed various types of ICSRs and assessed the reports for seriousness, causality, expectedness and responsible for resolving duplications and generating queries and performing due diligence. • Subject Matter Expert for Pre and Post-marketing reports and responsible for weekly update on the progress of the project under the supervision of the manager and preparing MOM. • Managed, mentored, and led a case management team of thirty (30) members for compliance and Quality Assurance (QA) activity of the project and monitored Noncompliance and Deviation reports. • Ensured all documents are submitted to the Trial Master File (TMF) as per the SOPs and sponsor’s requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing. • Ensured project planning i.e. timelines and deliverables, defining project management, quality management and project financial management.