Safety Management

PROFESSIONAL SUMMARY:

Over * years of drug safety experience with progressive growing carrier in clinical trials, post market studies and product complaints.

Around 2 years of exclusive experience working in Quality control, Compliance and CAPAs handling in PV area.

Excels in end-to-end ICSR case processing, aggregate reporting, and vendor monitoring activities and handling compliance metrics.

Worked in multiple therapeutic areas like Oncology, Endocrinology, Cardiology, Respiratory, and Infectious diseases.

Excellent experience in data manipulation/ QC of weekly, monthly, annual compliance metrics of global case submissions for quality and timeliness.

Knowledge of drug safety regulations and guidance (FDA, EMA, ICH) and expertise in the use of ARGUS, ARISg, MedDRA and WHO-DD.

Working knowledge on signal detection & risk management activities in Pharmacovigilance.

Knowledge of medical and drug terminology.

Highly proficient in Book-in, Triage, Data entry, Query generation and Narrative writing

Knowledgeable in various types of documentation reports: IND, NDA, Aggregate Annual Report, Periodic Report, and Expedited Report.

Able to work as an individual and as a part of a team, highly detail oriented and self-motivated. Able to prioritize, plan and organize work assignments and able to work under strict time lines and metrics environment. Have effective verbal and communication skills.

EDUCATION:

Masters in Toxicology from St John’s University, Queens, NY.

Bachelors in Pharmacy from Manipal University, INDIA.

SKILL SET:

Environment: Windows.

Office tools: MS-Office Suite, MS Visio

Database: ARGUS, ARISg, Trial Master, BI reporting.

PROFESSIONAL EXPERIENCE:

Allergan June2014–Till date

Patient Safety Compliance Specialist

Responsibilities:

Performing Quality Check (QC) of ICSR’s processed by partnering CROs; review the narratives, follow-up requests and coding adverse events in MedDRA in conjunction with medical monitors in preparation for finalization of reports as required.

Reviewing performance metric data (Key Performance Index) of the partnering CRO and analyze the inconsistencies and trends.

Assisting in signal detection activities, coordinating the SIRC meetings and building SOP’s, work instructions and developed process maps.

Attending kick off meeting for periodic reports and QC the periodic reports (PSUR, DSUR), followed up with in charge physicians, for the aggregate report analysis and information about the safety sections

Writing deviations as observed and closing the deviations by performing root cause analysis and implementing CAPAs.

Ensure compliance with safety data exchange agreements (SDEA) and appropriate archiving of all documentation of PV within the global database and designated areas.

Training new hires in case processing by presenting the SOP’s and work instruction.

Serving as a safety liaison contact to other departments (global clinical data management, regulatory, risk management) and licensing partners

Maintaining the PSMF log and working with QPPV office.

Supported for audit preparedness, maintaining training logs, and trained safety staff in routine quality review and case processing of adverse event reports.

Sarah Cannon Research Institute Jan2013 – May2014

Clinical Safety Associate

Responsibilities:

• Triaged, collected, monitored, processed, and distributed the serious adverse event reports to sponsor, regulatory authorities and project team within specified timelines.

• Performed SAE reconciliation of all adverse events (comparative review of Clinical and Safety database) and updated the identified discrepancies.

• Processed cases for different therapeutic areas such as: Oncology, Endocrinology, Cardiology, Respiratory, Infectious Diseases and Neurology.

• Performed Triage of incoming cases to determine seriousness for processing and reporting prioritization.

• Perform different case processing tasks in the safety database such as narrative writing, labeling and causality assessment, seriousness criteria, coding of drugs and adverse events through MedDRA and WHO-DD for reports originating from different sources such clinical trial and post marketing sources.

• Delivered presentations on quality improvement/training and presented weekly metrics to the line management.

• Handled the client audits adhering to ICH-GCP, process guidelines and SOPs on all assigned studies.

• Provided support during compliance inspections conducted by external sources as a scribe.

• Ensured compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.

• Participated in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics data provided to clients.

• Consulted Team Lead and Medical Review Safety Physicians whenever there were queries related to ICSR processing

4C Pharma Solutions June2011–June2012

Drug safety Assistant

Responsibilities:

Worked on Collecting, documenting, and processing Adverse Event and Serious Adverse Event reports from clinical trials and post-marketing sources.

Performing triage of incoming cases to determine seriousness for processing and reporting prioritization.

Performed initial book-in, duplicate case searches, and assessment of incoming reports.

Verified and reviewed all forms and documents pertaining to a case to identify errors, missing information, legibility.

Discuss any discrepancy with data with the Team Leader for resolution.

Actively participate in weekly team meetings and participate in inspection and audits as required.

ECRON ACUNOVA Dec2010-May2011 Intern-Clinical Research

Responsibilities:

Checked all eligibility and ineligibility criteria with the research subjects' medical record. Verified information with clinical research nurse and/or principal investigator.

Discussed informed consent with research subjects. Interacts with research subjects prior to entering the study and throughout the entire treatment. Assisted with scheduling appointments and follow up tests.

Learned protocol and monitored strict adherence to protocols by physicians, nurses and research subjects.

Reviewed protocol requirements with physicians, nurses and fellows. Identified any problems with protocol compliance and notifies principal investigator and/or research nurse.

Extracted data on protocol subjects from hospital records, outpatient charts and private physician office records in order to complete case report forms required by specific protocols.

Assisted with submission of expedited reports to Regulatory Authorities and Clinical Investigators. Ensured compliance with internal procedures, regulatory requirements.

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