Summary
Overview
Work History
Education
Skills
Timeline
Generic

Priyavadhana Moka

MA

Summary

Drug Safety Professional and Registered Pharmacist with 10 years of experience in all aspects of project management, ICSR case processing, assessing safety data, reporting and submissions, authoring aggregate reports for assigned products, performing signal management process and document management in Veeva. Expertise in MedDRA coding, expedited reporting and remarkable knowledge of US and ICH safety reporting regulations and guidelines. Providing root cause analysis (RCA) and implemented CAPA for authority. Local pharmacovigilance monitoring and perform impact assessments for regulatory documents. Experience in leading cross-functional teams and taking initiative to understand assignments. Core team member in PV automation (ArisG to LSMV, E2B R3 implementation) to meet regulatory requirements and strengthen drug safety. Signal Management (end-to-end) and performing Benefit-Risk Analysis and UAT testing. Experience in health authority inspections/internal audits and served as PV regulatory SME.

Overview

11
11
years of professional experience

Work History

Senior Drug Safety Scientist

EMD Serono
Rockland, MA
02.2019 - Current
  • Performing all pharmacovigilance tasks allocated to the Local Patient Safety Office which includes oversight of vendor activities and performance of key activities specified by the Food and Drug Administration
  • Tasks performed independently and specific expertise by a health care professional to ensure full compliance with all relevant global and local regulatory requirements and company standards including
  • Product safety surveillance
  • Handling of all local safety information, including collection, registration, and transmission to GPS as applicable in a timely manner
  • Oversight of vendor handling local safety information including collection, registration, and transmission to GPS as applicable in a timely manner
  • Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner
  • Oversight of follow-up activities performed in Patient Safety US including assurance that follow up information collected is medically relevant with coaching to LPSAs and Sr
  • LPSAs as required
  • Keeping product knowledge up-to-date to ensure appropriate Individual Case Safety Report (ICSR) handling
  • Performing required safety activities in the absence of the LPSO
  • Reporting to local Health Authorities and Ethics Committees
  • Determining medical relevance of new information received for follow up reports to determine reportability/submissions to the FDA
  • Monitoring of appropriate ARISg workflows to ensure timely submission of expedited ICSRs to FDA
  • Timely submission of expedited cases to concerned local/central EC/IRBs as applicable
  • Compliance related activities
  • Involvement in inspection readiness activities and deviation activities
  • Supporting the LPSO that a complete overview on local / global clinical studies and PDCS (planned as well as ongoing) in the local affiliate is kept
  • Ensuring local clinical trials comply with global standards and FDA requirements
  • Closely review of clinical study protocols (CSP)
  • As a member of pharmacovigilance intelligence team, performed impact assessments for the FDA guidances (including COVID-19 guidances) that are relevant to PV and act as a subject matter expert to ensure the relevant information was forwarded to concerned department
  • Conduct assessment and gap analysis relating to the impact of new proposed FDA regulations
  • Monitoring and assessment of new updates arising from FDA Health authorities (HA) which are available on intranet-based communication platform relevant to pharmacovigilance (PV) and new technologies in PV
  • Identifying validated signal and perform assessment, and signal notification to local health authorities
  • Involved in special projects related to combination product reporting and electronic submission of IND safety reporting to FAERS system
  • Performing SDEA (Safety Data Exchange Agreement) reviews and Safety Management Plan (SPM) reviews for certain clinical trial protocols
  • Supported the team with PVA’s to ensure timely and accurate processing and reporting of adverse events
  • Author for creating a PADER template version referencing the FDA guidance requirements
  • Review of aggregate report in timely manner
  • Provided and performed user requirements/safety specifications to configure for database upgrades
  • Performing SOP reviews and creating related tools (RT)/Managed Information linked to SOP’s
  • Review of completeness for line listing cases in each quarter
  • Conducting trainings for new hires

Drug Safety Specialist

Celgene Corporation
Summit, New Jersey
08.2017 - 02.2019
  • Reviewed case processing quality, coding, seriousness, listedness, causality assessments, narrative writing and overall consistency and provide feedback
  • Monitored internal and vendor timeliness to ensure compliance to company and global regulatory reporting requirements
  • Triage of safety data for ICSR creation in ARISg database and ability to convey complex and convey complex safety scientific data in an understandable way
  • Create phone call communication logs in ARISg Triage
  • Execute receipt of Drug Safety phone calls and complete telephone AE form
  • Strong background in FDA drug safety guidelines
  • Assessing the validity and causality of potential serious case
  • Responsible for confirming the data in minimal fields like latest received date, primary or secondary source, country of occurrence, reporter and assess regulatory relevance of follow up received, designated medical events/events of interest etc
  • Monitored ESM and electronic mailboxes to ensure timely acceptance of Adverse Event (AE) Reports
  • Assessment includes execute QC on key fields of serious cases and update key fields in ARISg based on QC, as needed
  • Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding and determine the causality)
  • Create and write clear concise clinical case narratives and review, update auto-narrative as needed
  • Performed event rankings based on SUSAR criteria and make dechallenge/rechallenge determinations for an appropriate causality assessment
  • Create company pharmacovigilance comments for causality assessment
  • Expertise in writing summary of analysis of similar events
  • Determine follow-up needs for AE reports and create targeted follow-up letters to the prescribers and other health care professionals
  • Review and update generated follow-up letters as appropriate
  • Perform major modifications following Medical Review
  • Assisted in the preparation of training material, prepared the team for and presided over audits, mentored PV staff and new hires in collaboration with PV Training team
  • Participated in preparation and reviewed relevant PV Standard Operating Procedures (SOPs), departmental Work Instructions (WI), training and other standard material required for PV staff
  • Participated in the generation of monthly status report ensuring quality and accuracy of metrics/data are provided

Data management analyst (Pharmacovigilance)

Accenture Services Pvt. Ltd
10.2013 - 07.2016
  • Clinical Safety Scientist:
  • Perform Peer QC check (quality control) for serious and fatal ICSR's
  • Evaluation and QC of Serious Adverse Events / Post Marketing Adverse Events to ensure accurate and consistent data entry and processing from source documents, with emphasis on timelines and quality
  • Ensure accurate and consistent coding of medical history, drugs, and adverse event terms
  • Assess adverse event reports for seriousness, causality, and expectedness as per applicable labelling (CDS, EMEA, PI and USPI), consulting the Medical Safety Expert whenever needed
  • Interpret patient-specific drug related data and identify specific drug related problem
  • Alert the Medical Safety Physicians to potential safety issues
  • Performed aggregate safety analysis and case level review, writing, planning, conducting meetings, and project management/coordination of strategic safety documents PSURs/PBRERs, PADER
  • Worked together with team members and safety physicians
  • Experienced working on multiple projects in all aspects of MedDRA and WHODD coding, causality assessment, labeling and narrative writing in ARGUS
  • Experienced working with cross functional teams at vendors and CRO companies
  • Adherence to company SOPs, styleguides, word templates, regulatory and ICH guidelines
  • Ensure continuous knowledge up gradation of self and the respective team in coordination with the client
  • Ensure good knowledge in diseases, their pathophysiology, drugs, and their mechanism of actions
  • Ensure updates of ORACLE ARGUS safety knowledge database
  • Number, timeliness, and scientific quality of deliverables as per established directives
  • Consistent demonstration of company values/behaviors
  • To mentor and train new hires or other associates
  • Open to get trained and move across roles based on business requirements
  • Handling and supporting in the tracking of excels, allotment, re-allotment of the cases to SPE’s based on priorities
  • Reconciliation of the cases to update the clients and maintaining reconciliation trackers
  • Plan and organize work so that all the applicable and agreed SLAs are realized
  • Conduct team meetings and discuss on the errors and the new conventions in PV process to ensure high standards of quality
  • Safety Process Expert:
  • Ensure safety of PMS studies
  • Responsible for initial checks, search database to prevent duplicate entries
  • Triage of incoming reports to determine seriousness for prioritization of daily workflow as well as for completeness and validity
  • Processing ICSR's (individual case safety reports) received from spontaneous reports and PMS with a high standard of accuracy in compliance with DS&E rules, standard operating procedures, and global regulatory requirements
  • Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
  • Data entry (DE) from ICSR’s and narrative writing with high quality within Service Level Agreements (SLA's) agreed with the client
  • Do medical coding of all serious and non-serious adverse events of ICSR's, medical history and laboratory data using MedDRA
  • Narrative writing to summarize safety data as per regulatory guidelines
  • Peer review, QC check to ensure Quality and Accuracy
  • Determine if appropriate case follow up has been considered
  • Conduct follow up activities when needed
  • Experience in client server application development (ARGUS Safety Web tool 7.0.5 Version, developed and designed by ORACLE) using Oracle SQL language

Education

Masters in computer’s and information sciences (MCIS) -

Southern Arkansas University
Magnolia, AR
01.2017

Masters in Pharmacy (Pharmacology) and Certified Pharmacist -

Andhra University
Andhra Pradesh, India
01.2012

Bachelors in Pharmacy -

Acharya Nagarjuna University
Andhra Pradesh, India
01.2010

Skills

  • Drug Safety
  • Project Management
  • ICSR Case Processing
  • Safety Data Assessment
  • Reporting and Submissions
  • Aggregate Report Authoring
  • Signal Management
  • Document Management
  • MedDRA Coding
  • Expedited Reporting
  • US and ICH Safety Reporting Regulations
  • Root Cause Analysis
  • CAPA Implementation
  • Pharmacovigilance Monitoring
  • Impact Assessments
  • Cross-Functional Team Leadership
  • PV Automation
  • Benefit-Risk Analysis
  • UAT Testing
  • Health Authority Inspections
  • PV Regulatory SME
  • Product Safety Surveillance
  • Local Safety Information Handling
  • Follow-Up Activities
  • FDA Reporting
  • ARISg Workflows
  • EC/IRB Submissions
  • Compliance Activities
  • Clinical Trial Oversight
  • PV Intelligence
  • Combination Product Reporting
  • IND Safety Reporting
  • SDEA and SPM Reviews
  • Adverse Event Processing
  • PADER Template Creation
  • Database Upgrades
  • SOP Reviews
  • Line Listing Completeness Review
  • Training and Mentoring
  • Peer QC Check
  • Serious Adverse Event Evaluation
  • Medical Coding
  • Narrative Writing
  • Aggregate Safety Analysis
  • PSURs/PBRERs/PADERs
  • MedDRA and WHODD Coding
  • SOP and WI Preparation
  • Monthly Status Report Generation
  • Clinical Safety Scientist
  • Safety Process Expert
  • PMS Study Safety
  • ICSR Processing
  • Data Entry
  • Peer Review
  • Case Follow-Up
  • Research
  • Data Collection
  • Data Analysis
  • Market Research
  • Data Validation
  • Data Forecasting
  • Good Communication Skills
  • Verbal and Written Communication
  • Interpersonal Skills
  • Hardworking
  • Confidence
  • Flexibility
  • Ability to Work Under Stressful Conditions
  • Time Management
  • Responsibility
  • Computer Skills: Windows XP, Microsoft Office, HTML, DBMS, SQL

Timeline

Senior Drug Safety Scientist

EMD Serono
02.2019 - Current

Drug Safety Specialist

Celgene Corporation
08.2017 - 02.2019

Data management analyst (Pharmacovigilance)

Accenture Services Pvt. Ltd
10.2013 - 07.2016

Masters in computer’s and information sciences (MCIS) -

Southern Arkansas University

Masters in Pharmacy (Pharmacology) and Certified Pharmacist -

Andhra University

Bachelors in Pharmacy -

Acharya Nagarjuna University

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Priyavadhana Moka