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Works for Sanofi Aventis.

- Triage of ICSRs to determine whether they qualify for expedited reporting or not and the
timelines within which they need to be submitted to the regulatory authorities
- Management of case data and registration of ICSRs into the safety database and conduct
of follow-up activities related to local AE reports
- Medical review, accuracy and completeness of Serious Adverse Event Reports for all case
types (spontaneous, clinical studies and solicited programs) including identification of
requirements of follow-up information.
- Regulatory assessment (seriousness and expectedness/relatedness) of the cases for
expedited reporting.
- Expertise in MedDRA coding in accordance with “MedDRA Term Selection: Points to
Consider” and WHODRUG knowledge
- Expertise in managing safety data on various safety databases
- Expertise in handling cases involving medical devices
- Critically evaluate, analyze, and interpret the medical literature to select primary resource
materials
- Manage workflow; identify and escalate issues
- Global trainer

Trained in MeDRA coding.


Trained in International Drug Safety Regulations including: ICH guidelines on safety and
efficacy, Volume 9A, FDA guidelines, CIOMS and New EU PV legislation.
Awareness of global regulatory reporting obligations and organizing workload to ensure
compliance with internal and regulatory timelines for adverse event reporting.
Trained in handling the ERP systems (Enterprise Resource Planning)

- Interacts with internal or external contracts to resolve issues related to the processing of
adverse events reports
- Maintains excellent knowledge of the AE safety profile of assigned drugs, labeling
documents, data capture conventions and guidelines and the costumer procedures.
- Preliminary data entry in the Electronic Case Registration (ECR) system
- Provides input, where applicable and as necessary, into data capture
conventions/guidelines/procedures/coding manuals
- Learning and applying of standard operating procedures (SOP’s) involved in good clinical
practice.

Management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous,
E2B, clinical studies and solicited programs).
• Captured data in the safety database, including determining the expectedness of adverse
events against various labeling documents (such as SPC, CDS, IB etc.), laboratory tests,
concomitant and corrective medication, medical history, concurrent conditions, assessing
causalities and writing company comment if required.
• Expertise in MedDRA coding in accordance with “MedDRA Term Selection: Points to
Consider”.
• Writing a detailed medically oriented description of the events in the form of safety
narrative.
• Identify clinically relevant missing information and initiating follow-ups for the collection of
new and clinically significant data as well as for medical confirmations as required.
• Reporting of potentially identifiable SUSAR to investigators and ethic committees.
• Writing PSURs, PBRERs and DSURs for different Pharmaceutical Drugs.
• Expertise in handling the ERP systems (Enterprise Resource Planning).
• Maintain an awareness of global regulatory reporting obligations and organizing workload
to ensure compliance with internal and regulatory timelines for adverse event reporting.
• Highlight any issues emerging from the QA results to the Project Manager and Associate
Project Manager.
• Risk Management activities including Signal Detection.
• Assisted the Project Manager in implementing Corrective and Preventive Actions (CAPAs)
for deviation.
• Interacting with appropriate client personnel to resolve issues related to the processing of
ICSRs in accordance with clients' requirement
• Received training as a trainer ("Train the Trainer") and mentor.
• Mentored safety personnel to ensure confident coding of ICSRs and creation of adverse
event forms.
• Providing training to affiliates located at different sites via live meetings and video
conferencing.

he healthcare industry is a huge world in itself. I completed the Bachelor's of Pharmacy in


2011, and every year since I have been learning newer concepts and fundamentals of the
industry.

I am a highly motivated and result driven pharmacy professional with 3.5 years of work
experience in German multinational company Boehringer Ingelheim as a
Pharmacovigilance Officer and Executive- Development project with strong working
knowledge of ICSR processing, MedDRA coding,drug development,document
management, ICH-GCP, EMA guidelines on drug safety. My exposure to
Pharmacovigilance audit has given me hands on experience to obtain an enhanced level of
understanding to achieve a robust Pharmacovigilance system. My role have also allowed
me to improve my management skills which I have developed with the responsibilities of
both project and people management.

I possess effective oral and written communication skills. I thrive as both a team member
and individually. I have exceptional organisational skills and work well within predefined
timelines under pressure.
PROFESSIONAL ACCOMPLISHMENTS
Received Excellence Award: Managed significant work load without impacting compliance
rating, Innovated new and effective ways of PV awareness,exhibited team work and
contributed in process development, successfully managed audit for Drug Safety function
within organization in 2015, Involved proactively in AE reporting training.

Therapeutic specialty include Oncology, Cardiology, Neurology, Diabetology.

Specialties:Key Areas of Expertise:

• Evaluation, processing and regulatory submission of Adverse Events from all sources
• Impart training on Adverse event reporting
• Document Management
• Periodic reconciliation for AE with all medical information, sales and marketing, Patient
support programs, market research

I am currently seeking an opportunity in healthcare industry in the areas of clinical trial, risk
management, drug safety, regulatory affairs and medical information.

Triage, Prioritization, managing departmental adverse event (AE) reports intake from
spontaneous sources, clinical trials, studies and marketing activities (including healthcare
professionals and consumers) in accordance with company standard operating procedures
(SOP) and guidelines for maintaining regulatory compliance
• Case entry in Global safety database, SCEPTRE, determination of seriousness,
expectedness, Lack of efficacy
• Track AE reports due to Health Canada, Global Medical Organization and affiliates to
ensure compliance as per SOP, PV agreement and regulations
• Reconciliation with internal and external business partners, AE Data management,
Document archival
• Training departmental personnel, new team members for Drug Safety, Follow up,
compliance process
• Answering medical enquiries in coordination with Medical Information team, Global
Medical Organization of Johnson & Johnson
• Liaise with internal and external business partners, HCPs and consumers to obtain
complete case information and documentation
• Strategic planning for process improvement for efficiency in coordination with the team.
• Providing ad hoc support for drug safety related requests
• Liaise with compliance team for and CAPA (Corrective Action/Preventative Action)
development.
• Adhoc leading support to follow team for troubleshooting
• Responding to queries and international affiliates as required for operational (e.g. queries),
compliance and/or safety functions

Managed and processed adverse events (collecting, processing and reporting) in


accordance with company standard operating procedures (SOP) and guidelines for
maintaining regulatory compliance.
- Prioritized adverse event reports (triage) and assessed regulatory status (seriousness and
expectedness/relatedness) to ensure timely reporting of reportable AEs to Health Canada
- Determined and conducted follow-up actions as required through appropriate
communication methods (e.g. fax, email, telephone).
- Requested product complaint investigation (e.g. PQMS number) on appropriate cases
according to the SOP.
- Provided overage to all products/devices as assigned.
- Responded to GMS and international affiliates as required for operational (e.g. queries),
compliance and/or safety functions.
- Performed other tasks as assigned

Assisted in the establishment and updating of a comprehensive PV system for BPL.


-Co-authored, updated and implemented 22 PV specific SOPs.
-Ensured that BPL complied with applicable global drug safety regulations & guidelines.
-Provided updated guidance regarding medical/ drug safety/ regulatory decision making.
-Developed PV Training Presentations and Training Material.
-Developed and implemented an extensive Training Program for new PV recruits.
-Provided rotating coverage for all drug safety related issues that arose during non-business
hours, weekends, and holidays.
-Escalated safety observations and alerts when necessary and initiated action when
required.
-Assisted in the setup of an In-house Software for Adverse Event Reports.
-Ensured that triage of received information was adequate and that ADE reports, whether
expedited or periodic/aggregate were processed and evaluated accordingly.
-Received, reviewed and processed relevant drug safety information that arose from BA/BE
and other clinical studies accordingly.
-Performed relevant Literature Search activities to detect ADE safety reports or other
relevant drug safety information.
-Prepared a Case report for every valid ADE case, comprising of a detailed case narrative,
MedDRA coding, medical review, seriousness, expectedness and causality assessment,
and other related information.
-Ensured that all cases, with the relevant safety information including follow up information,
are reported in prescribed formats and are submitted to Drug Regulatory Authorities in a
timely manner.
-Performed review of Periodic/Aggregate Reports and other relevant safety reports and
maintained timelines as required.
-Participated in writing safety reports (Risk Management Plans, Periodic Safety Update
Reports), Reconciliation Plans, and other Safety-specific plans as required.
-Performed monthly reconciliation of exchanged relevant information with relevant
stakeholders.
-Prepared articles for the medical newsletter

Triage, Prioritization, managing departmental adverse event (AE) reports intake from
spontaneous sources, clinical trials, studies and marketing activities (including healthcare
professionals and consumers) in accordance with company standard operating procedures
(SOP) and guidelines for maintaining regulatory compliance
• Case entry in Global safety database, SCEPTRE, determination of seriousness,
expectedness, Lack of efficacy
• Track AE reports due to Health Canada, Global Medical Organization and affiliates to
ensure compliance as per SOP, PV agreement and regulations
• Reconciliation with internal and external business partners, AE Data management,
Document archival
• Training departmental personnel, new team members for Drug Safety, Follow up,
compliance process
• Answering medical enquiries in coordination with Medical Information team, Global
Medical Organization of Johnson & Johnson
• Liaise with internal and external business partners, HCPs and consumers to obtain
complete case information and documentation
• Strategic planning for process improvement for efficiency in coordination with the team.
• Providing ad hoc support for drug safety related requests
• Liaise with compliance team for and CAPA (Corrective Action/Preventative Action)
development.
• Adhoc leading support to follow team for troubleshooting
• Responding to queries and international affiliates as required for operational (e.g. queries),
compliance and/or safety functions