Dr. Anuja Jawale (Sawant)

Head and Responsible for Pharmacovigilance and Medical Safety Activities in India and South Asia Cluster

Build and Manage Processes to facilitate Outsourcing of RA and PV activities Manage Out-Sourced Activities to support on-time execution of tasks Collaborate with Internal and External Stakeholders for smooth functioning of RA and PV processes Provide Regular feedback to Vendors

Build and Manage Processes to facilitate Outsourcing of RA and PV activities Manage Out-Sourced Activities to support on-time execution of tasks Collaborate with Internal and External Stakeholders for smooth functioning of RA and PV processes Provide Regular feedback to Vendors

Deputy Pharmacovigilance Officer In-Charge (PvOI) for Abbott, India. Designated person at Abbott to head pharmacovigilance operations for India, Nepal, Sri Lanka, Bhutan and Maldives (approximately 800 products). Liaison between local PV operations for the countries with my Global PV department and Medical Director. Ensure that all PV standards and processed as laid by global team are implemented in the countries. Ensure that the local regulations as required by the countries are implemented in the local PV system. Manage the quality systems and compliance activities. Provide pharmacovigilance inputs and review safety related data for activities from Clinical Development (CRF, protocol, monitoring plans, trainings, data review meetings, ongoing study assessment, blinded data review, reconciliation and CSR) to Clinical and Medical Research (Contracts and Agreements, trainings, CRF, Protocol, Safety review plans, interim study assessments, CSR and publications) to Post Marketing Activities like promotional materials, Patient Support Program, Market Research Surveys, Digital Programs and activities like Health Hazard Assessment. Responsible to implement Abbott PV standards for vendors which are involved in various commercial projects of Abbott (mostly in MRS and PSP and Social Media Programs).

Oversee PV operations of regions namely India, USA, EMEA, Australia, South Africa, Brazil, Mexico, Ukraine, Canada, Japan, Philippines. Ensure training, and understanding of the systems and processes to the Affiliates Preparation of SOPs for Affiliates Pharmacovigilance teams Ensure monthly compliance, maintain track and list all developments. Ensure robust mechanism of the pharmacovigilance process. Interact with cross functional teams to achieve a collaborative result. Led and completed migration of safety database from one DB to another DB.

Case Processing and Database validation Regulatory Submission of ICSRs Safety Data Exchange Agreements

Case Processing and Database validation Regulatory Submission of ICSRs Safety Data Exchange Agreements Compliance tracking Literature Search

Case Processing Literature Search Reconciliation

Worked as a Subject Matter Expert (SME) and Drug Safety Associate (DSA) at TCS since April 2009. As an SME reviewed invalid cases received from associates and authorized to approve as an invalid case and take decision on information whether valid or invalid with adherence to regulatory submissions. As a DSA responsible to analyze and interpret ICSR’s received from trial sites according to study specific trial protocol, criteria and Sponsor work instructions..

Documentation and Filing, Maintaining of Trackers and database. Receiving information in the form of SAE forms from Clinical cases from the Medical Affairs Department and forwarding them to the global database. Collection of Spontaneous ADR and reporting appropriately. Ensuring the submission of cases within timelines to the DCGI. Follow up for SAE’s with concerned people. Assisting in preparation of PSUR. Assisting Affiliate Pharmacovigilance Head in PViG related activities

Exposed to Phase IV and Drug Surveillance Trials. Verification of CRF’s and DCF’s. Reporting of SAEs to Pharmacovigilance department. Generating and resolution of queries from the investigator. Documentation and Filing