☛ Plan, conduct, and report the pharmacovigilance (PV) audits of client projects, internal systems, and service providers.☛ Prepare the risk assessment tool, perform the risk assessment and planning of PV audits as per risk assessment outcome. ☛ Prepare the strategic audit plan, and tactical audit plan. Oversight of the planned PV audits.☛ Hosting of Client PV audits and Health Authority Inspections. ☛ Supporting the CAPA management in audit and inspection related CAPAs. Tracking, review and management of audit and inspection CAPAs.☛ Assist in all audits related activities and follow-up till satisfactory closure of findings and implementation/verification of CAPA.☛ Prepare reports to communicate outcomes of quality activities.☛ Draft and/or review of company standard operating procedures (SOPs), Work instructions (WI) and such other documentation.☛ Liaise effectively and maintain excellent relationship with the clients and internal/external contacts for specific CAPA & quality deliverables.☛ Interpret and implement quality assurance standards.☛ Liaise with quality representatives, internal customers, and external customers across APCER's global offices as required to achieve quality objectives.☛ Support the deviation handling process and change control process if required, as back-up.

◄Work Responsibilities►A. Pharmacovigilance Quality Assurance activities:☛ QA Lead - Pharmacovigilance Quality Assurance and compliance activities.☛ Plan and conduct audits of global pharmacovigilance activities such as literature screening, ICSR processing & submission, reference safety information, aggregate/periodic reporting, signal management, risk management, pharmacovigilance SDEA, PSMF, QPPV etc.☛ Plan and conduct audits of company affiliates, business partners, service providers/vendors.☛ Conduct qualification audits of potential new vendors providing pharmacovigilance services.☛ Development of the risk based PV audit, tactical and strategic audit plans.☛ Lead in the preparation, hosting and follow up audits from licensing partners related to pharmacovigilance activities. Provide audit response, corrective actions, and/or preventive actions to partners.☛ Lead in the preparation, hosting and follow up inspections from regulatory/health authorities. Provide response, corrective actions, and/or preventive actions for identified non-conformance.☛ Develop QA SOPs and audit plans.B. GCP Audits & Compliance☛ QA Lead – GCP audits and compliance activities.☛ Conduct audit of phase-3 clinical trial at investigator sites for Biosimilar and small molecules.☛ Conduct qualification audit of clinical vendor.☛ Develop QA SOPs and audit plan.

◄Work Responsibilities►A. Pharmacovigilance Audits:☛ Plan and conduct audits of pharmacovigilance activity. ☛ Execute pharmacovigilance audit program (including audits of critical processes, affiliates, licensing partners, service providers/vendors).☛ Conduct qualification audits of potential new vendors/partners providing pharmacovigilance services.☛ Lead and/or participate in the development of the risk based PV audit, tactical and strategic audit plans.☛ Lead and/or support in the preparation, hosting and follow up audits from licensing partners related to clinical safety and pharmacovigilance activities. Provide audit response, corrective actions, and/or preventive actions to partners.B. GCP / GLP Audits☛ Conduct audits of assigned clinical trials at investigator sites.☛ Conduct audits of clinical and bio-analytical phase of bioequivalence studies at CRO sites and remotely. ☛ Conduct audits of clinical study and regulatory submission documents including clinical study report, trial master files, informed consent documents, bio-analytical report, method validation reports, STP/SOPs, chromatograms etc.☛ Conduct selection and qualification audits of domestic & international vendors/CROs providing clinical, bio-analytical and pre-clinical services. ☛ Conducts internal system/process audits to ensure compliance with company policies/procedures and GCP/GLP or GVP regulations.☛ Prepare QA audit reports for audits performed. Perform peer review of audit report. Prepare & establish QA SOPs; review cross-functional SOPs.☛ Support regulatory team in preparation of response for the deficiencies / non-conformities observed by regulatory authority in the submitted ANDA.

◄Position Summary►☛ Research Associate –From October 2010 to March 2013☛ Scientist – From April 2013 to November 2013☛ Conducted in-process and retrospective audits of Bioequivalence clinical studies. Conducted audit of dosing, dispensing, phlebotomy, study protocol, clinical study report, screening records, ICDs, CRFs, drug accountability records, logbooks etc.☛ Conducted in-process and retrospective audits of bio-analytical studies. Conducted audit of bioanalytical method validation, study sample analysis, sample processing, bio-analytical study plan & report, validation protocol, method validation report, study raw data, chromatograms, logbooks etc.☛ Conducted internal system audits to ensure compliance with company policies/procedures and GCP/GLP regulations.☛ Handled and compiled Module 5 of eCTD for dossier submission (ANDA) to regulatory authority. ☛ Supported regulatory/operations team in preparation of response for the deficiencies/non-conformities observed by regulatory authority in the submitted ANDA and/or during regulatory inspection at BE center. ☛ Actively participated in regulatory inspections of MHRA (UK), ISPCH (Chile), DCGI (India). ☛ Conducted training of new and present employees at BE center on in-house SOP’s, company policies, regulatory guidelines. ☛ Prepared & established QA SOPs and reviewed clinical, bio-analytical, PK & Statistics dept. SOPs. ☛ Performed quality compliance activities including SOP approval, deviation, incidents, CAPA and change management.

☛ Performed Bio analytical Method Validation for supporting BA/BE studies.☛ Performed subject sample analysis for BA/BE studies.