Senior Pharmacovigilance Scientist

Professional Summary

Qualification

M.D. Pharmacology (Doctor of Medicine) India, 2012-2015.

M.B.B.S. (Bachelor of Medicine, Bachelor of Surgery), India 2000-2006.

Skills

Pharmacovigilance Experience:

Expertise in regulatory compliance, with a focus on key guidelines and regulations including ICH (particularly E2C[R2]; GVP modules VII, IX; Volume 9A, CIOMS) and FDA (CFRs).

Proficient in writing, compiling, and coordinating various aggregate reports such as PBRERs, DSURs, Ad hoc reports.

Skilled in signal management and risk management activities including RMP/REMS implementation.

Proficient in analyzing diverse datasets including clinical, literature, safety, medical, and trending data, as well as labeling documents for aggregate reports.

Strong grasp of medical concepts, with expertise in causality assessment, risk assessment, and de-challenge/re-challenge determination.

Trained in WHO MedDRA coding for safety analysis purposes, ensuring accurate and consistent data classification.

Proficient in narrative writing, with the ability to effectively communicate complex associations and adverse drug reactions.

Familiarity with Pharmacovigilance databases such as ARGUS, ARISg, SCEPTRE, and Vigibase, facilitating efficient data management and analysis.

Capable of collaborating across multiple functions including clinical, biostatistics, regulatory, clinical-operations, data management etc.

Possess comprehensive analytical and conceptual skills for safety analysis of both investigational and marketed products.

Proficient understanding of Institutional Review Boards (IRBs), Good Clinical Practices (GCPs), and Quality Assurance/Quality Improvement (QA/QI) activities, ensuring adherence to ethical standards and regulatory requirements.

Skilled in the preparation and meticulous review of protocols and Informed Consent Forms (ICFs), guaranteeing clarity, compliance, and participant safety throughout clinical trials.

Demonstrated ability in effectively coordinating projects and conducting research-oriented tasks, facilitating seamless collaboration among multidisciplinary teams and ensuring project milestones are achieved within timelines and budget constraints.

Clinical

Served as on-call physician in various hospitals, conducting patient assessments and coordinated patient care plans.

Established and managed a successful private practice and provided patient care as primary care physician (PCP).

Demonstrated excellence in clinical diagnosis and management of acute and chronic conditions, with a commitment to staying updated on the latest medical advancements.

Cultivated strong patient relationships, fostering trust and adherence to treatment through effective communication and empathy.

Regulatory

Extensive knowledge of global, regional, and local regulatory requirements across key markets including the US, EU, Asia and Canada. Familiarity with FDA regulations (CFRs), EU regulations, MHRA guidelines, and ICH guidelines.

Proficient in preparing and reviewing safety specific regulatory submission applications for sNDA, ensuring compliance with regulatory standards.

Skilled in regulatory strategy management, program management, and navigating the clinical development process. Experienced in drafting protocols, informed consent forms (ICFs), and adhering to Good Clinical Practices (GCPs).

Proficient in crafting global and local labeling documents such as CCDS, CCSI, IB and USPI.

General

Exceptional Communication: Proficient in articulating ideas clearly and concisely, facilitating collaboration and information dissemination among teams and stakeholders.

Digital Proficiency: Skilled in Microsoft Office Suite (Project, Outlook, Word, Excel), Adobe software, enhancing productivity through digital tools.

Strong Problem Analysis: Ability to quickly grasp new concepts, coupled with strong problem-solving skills to adapt to evolving business needs and technological advancements.

Data Management Excellence: Demonstrated proficiency in data management, documentation, and organization, ensuring accuracy and accessibility critical for decision-making.

Collaborative Leadership: Proven track record of motivating and inspiring team members, fostering a supportive work environment conducive to innovation and growth.

Effective Task Management: Capable of prioritizing and managing multiple tasks concurrently, utilizing strategic planning and time management techniques to meet deadlines consistently.

Strategic Thinking: Proficient in developing and executing strategic plans aligned with organizational objectives, driving business growth and competitive advantage.

Mentorship and Coaching: Experienced in providing mentorship and coaching to foster professional development and career advancement among team members.

Sound Decision Making: Demonstrated ability to make timely and informed decisions under pressure, leveraging analytical thinking and risk assessment.

Change Management: Proficient in leading change initiatives, fostering resilience and adaptability among team members to drive continuous improvement.

Total Experience

9 years in Pharmacovigilance/Drug Safety,

4+ years in Clinical practice

Career Timeline

Jul,2020 – Present – Senior Pharmacovigilance Scientist, Takeda, NJ USA

Jul, 2017-Jul, 2019 – Safety Physician, Johnson & Johnson, Raritan, NJ USA

2015-2016 - Associate Medical Safety Advisor, Quintiles Research India (now, IQVIA)

2012-2015 – M.D Pharmacology. Worked as Resident Pharmacovigilance Physician

2006-2009 – Clinical practice

Professional Experience

A passionate physician with clinical experience and specialization in oncology patient safety research. Committed to upholding high ethical standards while delivering patient-centered care. Enthusiastic about continuous professional development. Dedicated to advancing healthcare through meticulous safety monitoring and expertise.

Senior Principal Pharmacovigilance Scientist (Sr. Manager role) Takeda Pharmaceuticals, MA

July 2020 – Present

Development program (Phase 1), T-cell engager, indicated in unresectable, locally advanced or metastatic solid tumors. April 2023 – Present

Spearheaded day-to-day pharmacovigilance (PV) activities including safety surveillance, signal detection [global safety team (GSTs) meetings], signal evaluation report, and risk management activities, reviewing global safety data from multiple sources including individual patient data, cohort level data, aggregate data, and literature review.

Represent pharmacovigilance, both regionally and globally, as an authoritative and knowledgeable member of Global Program Teams (GPTs) and sub teams including clinical study teams (CSTs), non-clinical sub team meetings, investigator meetings, study execution team (SET) meetings etc.

Represent the safety team at cross-functional meetings, actively contributing to safety analyses, discussions and presenting PV data to support program objectives.

Led the preparation and presentation at safety management team (SMT) meetings by partnering with cross-functional colleagues to contribute to safety-related deliverables associated with benefit-risk assessments and activities related to risk minimization including RMP.

In collaboration with the GSL, worked on the first Benefit-Risk Assessment Categorization Tool (BRACT) for the product. Facilitated the cross-functional review of the BRACT.

Support cross-functional assessment of benefit-risk by analyzing and interpreting safety data from various sources including non-clinical, clinical and scientific literature.

Led and performed in depth analysis of TCE related risks to support various assessments and safety conclusion for the purposes of signal evaluation (Empirica), SMTs, protocol amendments, memos etc. which included review of COGNOS report (aggregate safety database), patient dynamic listings and Medidata (clinical database).

Led in collaboration with GSL, extensive preparation for the discussion of major safety concerns at the Takeda Safety Board.

Led preparation in collaboration with GSL for FiH Takeda Safety Board that included collaboration with cross-functional functions.

Led the preparation of urgent external hepatic consultation in collaboration with Center of Excellence (CoE) of Target Organ Toxicity that included extensive assessment and preparation of data followed by review of opinion at ad Hoc SMT.

Supported and attended end of cohort (EOC) meetings by providing cohort aggregate safety data review to support decisions on dose-escalation, management of adverse events (AEs) including pre-medication etc.

Led updates and review of the safety documents for clinical study including informed consent form (ICF) safety language, development core safety information (DCSI), IB, RSI, protocol amendments, drafting dear investigator letter (DIL), clinical synopsis, tables, listings and figures (TLF) review etc. This included liaison with colleagues in relevant functional areas within and outside of PV to gather and provide input for appropriate sections of these critical documents.

Led and provided strategic guidance to vendors for authoring of aggregate safety reports including development safety update report (DSUR), 6 month suspected unexpected serious adverse reaction (6M SUSAR) report update by cross-functional collaboration, leading safety sections, and addressing regulatory queries, ensuring compliance with safety reporting requirements.

Reviewed public assessment reports like EPAR, USPI, shared by health authorities for online publishing, for a competitive assessment of other approved T-cell engagers.

Post-marketing program, indicated in Ph+ ALL July 2020 – July 2024

Lead Global Safety Scientist on assigned programs in oncology and provided expert pharmacovigilance support, assuming leadership roles as the lead when necessary.

As a key member of the product submission working group, conducted high quality assessments of safety data and key messaging in submission documents that included clinical study reports (CSRs), summary of clinical safety, clinical overview, integrated safety summary (ISS), Module 2.7.4, 2.5, FDA 90-day safety report.

Served as Subject Matter Expert (SME) during the Health Canada inspection, during which responded to a query request successfully.

Led monthly signal detection/safety monitoring activities (GSTs) that involved strategizing, analysis and review of all the safety data from multiple different sources including individual case safety reports (ICSRs) and literature review. This included reviewing medical cases on aggregate level, raising queries, performing qualitative and quantitative trend analysis.

Represented pharmacovigilance department in cross-functional teams (GSTs, SMTs, CSTs) or committees and external environments at a global and regional level as required, with the advanced communication skills this requires.

As a member of the labeling working group, supported the GSL during the FDA label negotiations. This also included determining the warnings & precautions and ADR selection methodology for inclusion in the labels.

Fostered collaboration with relevant functional areas, both internal and external to pharmacovigilance, to facilitate efficient and timely acquisition of compliant and patient-centric safety data.

Led the update of the risk management plan (RMP) for the assigned program in collaboration with RMP CoE, managing complexities around approvals and evolving safety profiles, collaborating with internal and external stakeholders, updates to core and local RMPs based on feedback from health authorities.

Provided expert review and input into the development of protocols, IB, RSI, Statistical Analysis Plans (SAPs), CSRs, ICF and other pertinent project documents.

Conducted and timely delivered ad hoc safety analyses, particularly in response to regulatory queries, to address safety concerns and support regulatory submissions.

Safety Surveillance Physician, Johnson & Johnson, NJ July 2017 – July 2019

Performed medical case review of individual case safety reports (ICSRs) (pre-clinical, clinical trial data, post-marketing, literature) and patient narrative, including review of source documentation as needed, in immunology and oncology therapeutic areas. This included MedDRA coding, expectedness and causality assessment individual events and a detailed company comment at case level.

Performed detailed assessment of SUSARs including which included drafting an analysis of similar events (AOSE) in addition to company comment and ensuring timely submission of the report.

Performed weekly aggregate analysis of serious and non-serious line listings to identify potential signals and/or Designated Medical Events (DMEs) from ICSRs.

Identify and evaluate new safety signals and trends by conducting systematic reviews of aggregate data.

Perform signal detection activities for oncology, immunology, established products (SMART daily alerts)

Perform validation of signals identified in reviews.

Prepare and present summary analysis of safety data for the SMT.

Worked in collaboration with Medical Safety Officers (MSO) in assessment of identified and potential risks as per GVP guidelines. Provide medical input with respect to potential and identified risks following detailed evaluation of safety reports.

As a safety physician provided important input in team discussions regarding preparation of RMP.

Vendor management to develop reports/deliverables and vendor performance evaluation.

Associate Medical Safety Advisor, Quintiles Research, India Dec 2015-Nov 2016

Led the team in the medical review of ICSRs that included clinical trial, post-marketing, pregnancy and literature reports.

Demonstrated active medical leadership in the implementation and execution of an improved labelling and causality assessment procedure (was rewarded with “Bravo”).

As the primary pharmacovigilance physician, I worked as the primary point of contact with the client and worked in association with the Safety Surveillance Group. In this role, I was responsible for evaluating weekly Watch list & DME line-listings and labelling issues.

Participated in cross-functional training of relevant stakeholders and SME for audits/inspections

Collaborated with multiple teams - operations, quality review, client Safety Surveillance Physicians (SSPs) - to ensure timely reporting of safety data of biologic drugs to Regulatory Authorities.

As a part of MedDRA coding participated in selection of appropriate Reported Reaction Term (RRT) which would match with the Preferred Term (PT), while conveying the medical concept

Trained case processing team on labelling and de/re challenge.

Resident medical officer in Park Neurosurgery Nursing Home Kolkata 2008-2009

As an active physician assisted in various neurosurgical emergencies

Intern under Dr. A. G. Ghoshal, A famous Pulmonologist in Kolkata 2008-2009

As a physician, examined patients, made provisional diagnosis and prescribed medications

Resident medical officer in the Department of Medicine, Peerless Hospital, Kolkata, March, 2008-August, 2008

Acted as the on-premise doctor responsible for patients including emergencies

Private Practice (General Physician) – Kolkata, India, 2007-2008

Medical Internship (Residency) – Thanjavur Medical College Hospital, 2005-2006

Publications/Presentations

Authored article titled “Quantitative and Qualitative analysis of prescriptions at a tertiary health care hospital” published in Journal “Drug and Therapy Perspectives”

(http://link.springer.com/article/10.1007/s40267-015-0243-8)

Presented oral paper on “Usage of antimicrobial prophylaxis for major surgical procedures in gynaecology and obstetrics” organized by Indian Pharmacological Society, at National Institute of Mental Health and Neuroscience, Bangalore, Karnataka, from 16 December 2013 to 18 December 2013.

Presented poster on “A study of the drug use pattern in different medical specialties using WHO prescribing indicators” at CME on “System, Monitoring in Critical Care” held at Ahmedabad on 21st Sep, 2014

Conferences/Workshops

Attended American Society of Clinical Oncologist (ASCO) conference in 2023.

Attended PHARMATECH- 2015, Mumbai, Theme : "Frontiers in Pharmacology" which included Pre-clinical Research, Clinical Research and Specialty Domains in Pharmacology

Attended Annual Conference of the Indian Pharmacological Society (IPSCON), Bangalore 2013. Topic: “Translating Research to Therapeutics" which included pharmacogenomics and personalized medicine, drug discovery current developments, advanced pharmacology of lifestyle diseases

Attended CME on “System, Monitoring in Critical Care” on 21 September 2014 organized by AMCMET Medical College, LG Hospital Campus, Ahmedabad.

Research

Conducted extensive research and submitted dissertation on “A Study of Chemoprophylaxis in patients undergoing major surgical and Gynaecological procedures” that included preparation of the protocol, data collection, analysis and presentation.

Education

Education

Education

Education

Education

Contact this candidate