Summary:

An experienced Drug Safety/Pharmacovigilance Scientist with 10 years of relevant experience with top pharma/biotechnology firms worldwide.

Significant experience in authoring and review of all safety regulatory document types (e.g., PSUR/PBRER, DSUR, PADER, CAR, ACO, RMP etc. and ad hoc safety responses to various Drug Regulatory Authorities).

Quality Control of CSRs, IB, briefing documents, RTQ’s, RMP’s, REMS, PRAC RTQ’s, Safety Assessment Reports and clinical overview documents.

Signal Detection Activities: Assist Safety Risk Lead in analyzing safety signal data retrieved from the signal detection tool and literature review and discuss the results with the TAH, SRL, and other key stakeholders.

Mentoring, training and coaching new employees on ICH regulations and company SOPs

Business process improvement: Developed QC score card for aggregate reports: tool for RCA and CAPA

Hands on expertise on various drug safety databases such as Argus, ArisG, Sapphire and tools such as Pfast (Pfizer Analytical and Statistical Tool), EPIC and GDMS. Proficient in MedDRA coding, ICSR (including medico-legal case) processing and narrative writing.

Lean Six Sigma Green Belt trained professional adept at applying the principles of Six Sigma. Actively involved in Project management related activities including TCS Integrated Quality Management System.

Ambitious, self-motivated individual with problem solving abilities and excellent communication skills. Ability to influence people, proven interpersonal skills and analytical thinking. Thorough, structured and strong organizational skills and ability to multi-task.

Skills:

Medical/Scientific Knowledge, Analytical skills, Effective Communication, Understanding relevant legal and related issues, Ethics, Workload management, Interpersonal skills, Accountability, Proactivity, Continuous development,

Project Management, Training and Mentoring, IT and Software skills: MS Office suite applications, SPSS, Smart Art, Drug safety databases: Argus, ArisG, and Sapphire, document management systems: EPIC, GDMS, tools such as Pfizer Analytical and Statistical Tool (Pfast) and PleaseReview.

Education:

Master’s in Health Informatics, New England College, New Hampshire, USA 2020

Master of Business Administration, Newcastle University Business School, Newcastle-Upon-Tyne, UK 2011-2012

Post-Graduate Diploma in Clinical Research, ICRI Mumbai, India 2007 -2008

Bachelor of Dental Surgery, The Tamil Nadu Dr. MGR Medical University, Chennai, India 2001-2007

Experience:

Biogen (Sr. Pharmacovigilance Scientist - External) May 2020 – Oct 2020

Boston, Massachusetts

Serves as product lead for pharmacovigilance activities within Safety.

Responsible for overseeing and leading the process of safety signal management activities, aggregate reports (PSUR, DSUR, line listings, RMPs).

Responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities

Serves as SME for Safety and Cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.

The role is critical to ensure products in clinical trials continue to maintain good standing with countries where studies are ongoing to ensure clinical studies are completed, and for marketed products, ensures the marketing authorization remains in good standing.

Pfizer Pharmaceuticals Apr 2019 – Sep 2019

Manager, Safety Evaluation and Reporting (Role: Aggregate Report Analyst)

To prepare clinical and post-marketing reports such as PADERS, CARs, ACOs, HHA, Ad-hoc reports, PSURs, PBRERs, RMPs etc.

Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission

Provide project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents

Analyses safety signal data retrieved from appropriate signal detection tool and literature review and discusses the results with the therapeutic lead and SRL physician and other key stakeholders

Assess document requirements, gauge document complexity, and identify information gaps or other potential issues

In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues

Lead a team of internal or external (contractor) authors if multiple or complex documents are required for a project

Support WSR teams by providing analyses of clinical data, post-marketing safety data, reviews of the medical literature, and similar related activities

Accountable for timely delivery of high-quality, fit-for-purpose documents to the project team

Training, Mentoring and Coaching of new joiners on company SOPs, aggregate report guidelines, Pfizer templates and processes.

Pfizer Pharmaceuticals Apr 2018 – Apr 2019

Deputy Manager, Safety Evaluation and Reporting (Role: Aggregate Report Analyst)

To prepare clinical and post-marketing reports such as PADERS, CARs, ACOs, HHA, Ad-hoc reports, PSURs, PBRERs, RMPs etc.

Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission

Provide project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents

Analyses safety signal data retrieved from appropriate signal detection tool and literature review and discusses the results with the therapeutic lead and SRL physician and other key stakeholders

Assess document requirements, gauge document complexity, and identify information gaps or other potential issues

In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues

Lead a team of internal or external (contractor) authors if multiple or complex documents are required for a project

Support WSR teams by providing analyses of clinical data, post-marketing safety data, reviews of the medical literature, and similar related activities

Accountable for timely delivery of high-quality, fit-for-purpose documents to the project team

Training, Mentoring and Coaching of new joiners on company SOPs, aggregate report guidelines, Pfizer templates and processes

Pfizer Pharmaceuticals Oct 2016 – Apr 2018

Assistant Manager, Safety Evaluation and Reporting (Role: Aggregate Report Analyst)

To prepare clinical and post-marketing reports such as PADERS, CARs, ACOs, HHA, Ad-hoc reports, PSURs, PBRERs, RMPs etc.

Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission

Provide project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents

Analyses safety signal data retrieved from appropriate signal detection tool and literature review and discusses the results with the therapeutic lead and SRL physician and other key stakeholders

Assess document requirements, gauge document complexity, and identify information gaps or other potential issues

In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues

Lead a team of internal or external (contractor) authors if multiple or complex documents are required for a project

Support WSR teams by providing analyses of clinical data, post-marketing safety data, reviews of the medical literature, and similar related activities

Accountable for timely delivery of high-quality, fit-for-purpose documents to the project team

iMED Global Solutions India Pvt. Ltd. Feb 2015 – Oct 2016

Specialist – Medical Writing

On deputation at Novartis, Hyderabad – Role - Medical Safety Writer Aug 2015 – Oct 2016

Lead preparation of global periodic safety reports for newly launched products

Lead coordination with Global Line Functions (GLFs) to ensure information received, analyzed and incorporated into Aggregate Reports (ARs) as per the regulatory requirements.

Independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Novartis standards

Support in creating strategy for data analyses and presentation in global periodic safety reports. Support in addressing the Health Authority (HA) comments adequately in PSURs.

Support in the development of safety document templates and SOPs pertaining safety aggregate reports

Aggregate Report Quality Reviewer Role – Johnson and Johnson Feb 2015 – Aug 2015

Manage and perform the Quality review process for aggregate reports within scope (which may include but are not limited to PADER, PBRERs, PSURs, SBRs, Any ad-hoc reports for the assigned products - small to high complexity reports, including planning, conducting planning meeting, coordinating of production modification, assembly in the Database, as appropriate

Ensure template is followed, develop templates as appropriate

Ensure Style Guidelines are followed

Ensure preparation of timely, quality aggregate reports for assigned products

Edit/align the documents to the customer's template

Assessment of the value/applicability and conciseness of written information contained in the draft document; verification of clinical safety data parameters for quality review of PSUR’s as agreed to in planning meeting.

Prioritization of simultaneous multiple tasks, and working with others to determine general document and/or timeline requirements and/or review or multiple reviews.

Tata Consultancy Services Sep 2013 – Feb 2015

Business Process Lead (Role: Safety Scientist – Amgen PV Standards)

To perform safety periodic writing including assessment, analysis, and Quality Control (QC) of all reports [Periodic Benefit-Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR)/, Development Safety Update Report (DSUR), Quarterly Safety Update Report (QSUR), Periodic Safety Report (PSR), Safety Assessment Reports (SAR) and Safety Progress Reports for South Africa (SPR SA) and India (SPR IND)] assigned by the supervisor.

To perform peer review of the assigned aggregate reports and complete the corresponding QC checklists.

To perform all Pre-DLP activities and planning for all assigned reports as per the Amgen training including conducting Kick off Meetings.

To request and ensure the receipt of contribution from the various stake holders necessary for authoring of the assigned reports.

To ensure the completion of authoring, QC, review and publishing of the assigned reports within the specified timelines in EPIC.

To understand and interpret data/information and its practical application.

To effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment.

To track and ensure that the progress of reports is as per the client defined timelines.

To provide daily progress update regarding the status of the assigned reports to the supervisors.

To ensure the timely completion of all activities and trackers maintained for the project.

To ensure the completion of all assigned project related activities assigned by the supervisors.

To ensure compliance to SOPs and other process related documentation.

Tata Consultancy Services Mar 2013 – Sep 2013

Business Process Lead (Role: Quality Control Associate – Amgen Global Regulatory Writing)

Perform Medical Writing activities:

Ensure quality of the documents objectively and accurately represent the data

Ensure that the clinical documents are approved and issued in accordance with the company SOPs, guidelines and agreed timelines

Develop and maintain effective working relationships and facilitate communication among the project team member

Responsible for quality check of documents and generating quality metrics so as to maintain quality control

Ensure compliance to SOPs, templates, document standards, style guides

Version Control, Change management, Training records, Training plan coordination, Process Compliance

Hands on experience on various document types:

CSR (Full CSR, Abbreviated CSR, Synoptic CSR, and Supplemental CSR), IB updates, FDA briefing Documents, PRAC Response to Questions (RTQs), Risk Management Plan (RMPs), Risk Evaluation and Mitigation Strategy (REMS), Clinical Overview documents, PSURs, DSURs and PBRER.

Therapeutic Areas: Oncology, Metabolic disorders, cardiovascular, endocrinology, inflammation disease

Tata Consultancy Services Dec 2009 – Sep 2011

Senior Process Associate (Role: Drug Safety Associate – Amgen Drug Safety)

Triage, process and Quality review ICSRs (non-serious and serious), literature documents originating from PM or observational studies in appropriate safety databases such as ArisG (Citrix Application) and Argus with the help of MedDRA v13.1.

Work-flow Management and point of contact for case processing related queries for new joiners.

Supported the team lead actively in work allocation and to ensure daily assignment is completed by the team and informing the team lead reasons for late cases.

Maintained trackers and ensured team’s time sheet compliance.

Tata Consultancy Services Feb 2009 – Dec 2009

Senior Process Associate (Role: Drug Safety Associate – AstraZeneca Medico-Legal Case Handling)

To process the litigation ICSRs assigned, capture serious and non-serious adverse events, to code events with the help of MedDRA and draft case narratives in the safety database Sapphire.

Knowledge of working on various Medico-Legal documents like Civil Complaint, Plaintiff fact sheet and Medical records

Experience in identifying Expedited Safety Reports (ESR) and knowledge of processing ESRs.

Certifications

Certificate of Recognition for embracing the Pfizer OWNIT! Culture (2017)

Certificate of Participation at the Pfizer Integrated R&D Day for Poster Presentation Titled “Systematic Knowledge Transfer – A Paradigm for Excellence” (2017)

Certificate of Completion awarded for completing TCS BPS – Lean SixSigma Green Belt Assessment (2014)

Certificate of Participation in the International Executive Summer Program in Design Management hosted by Grenoble Graduate School of Business, France (May-June 2012).

Attained a Pass in The Institute of Clinical Research (ICR), UK Certificate Examination (2008)

Certificate of successful completion of FDASmart Inc Programme – Understanding FDA and the FDA Approval Process – delivered by Dr. Joshua Sharlin – a former US FDA Reviewer (2008)

Rewards and Recognition

Appreciation from EU Regulatory Strategist for enabling the timely submission of Pfizer (MAH) Response to Methotrexate 2019 PSUR PRAC Preliminary Assessment Report (reporting period 01 July 2017 to 31 Oct 2018 with project management and leadership skills (2019)

OWNIT – Own the Business Award from Safety Risk Lead for the preparation of a SQR for an AQRT dealing with a potential carryover issue involving small volume products manufactured at the Pfizer Rocky Mount plant in North Carolina (2019)

OWNIT – Own the Business Award from Safety Risk Lead for the preparation of Pfizer (MAH) response to the MHRA notification dated 30 July 2018 regarding a possible signal of doxycycline and mood disorders (2018)

References Available Upon Request

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