Data Entry Pharmacovigilance Scientist
Resume:
RAJA VASUDEV. A
CHICAGO IL 60641-2338
Mobile: 803-***-****
*************@*****.***
Professional and Technical Summary:
Competent drug safety scientist with 11+ years of experience in various domains of Pharmacovigilance including case processing, signal detection aggregate reports and Risk Management Plan.
Authored and reviewed aggregate reports including PADER, PSUR/PBRER, ASR and DSUR, for respective regulatory agencies.
In-depth experience with case processing in both Clinical and Post-marketing settings.
Experienced in creation and management of Aggregate Safety Reports (ASRs) i.e. DSURs, and Local RMPs
Performed signal detection and evaluation according to SOPs and guidelines
Worked with ARGUS, ARISG safety databases PVEDGE and Clinevo database
Highly experienced with clinical databases, clinical data review and issuing safety queries to sites/investigators
Participated in the signal detection activities and safety analysis of the product with global safety experts and pharmacovigilance scientists by providing the line listings and appropriate data analysis for the data available in the safety/clinical databases, including review and analysis of ARGUS database
Assisted in creation and management of Aggregate Safety Reports (ASRs) i.e DSURs, PBRER, PADER, Local RMPs and Signal detection activities.
Possess sound communication skills both in verbal and written, good prioritization and time management skills
Proficient in development and implementation of Global regulations/guidelines, Standard Operating Procedures (SOPs), and training materials
In-depth experience with case processing in both Clinical and Post-marketing settings
Experience in managing, mentoring, and training fellow PV team members
Good decision-making, organizational, prioritization and problem-solving skills
Excellent ability in performing Quality check of Adverse Events, Serious Adverse Events based on approved case processing metrics
Ensures effective functioning of all PV projects in compliance with client agreement, contract; and local and global regulatory guidelines.
Responsible for quality management, workload management, compliance management and document management across all PV projects.
Manages project and resource allocation within the PV department. d. Monitors workload of department and alerts the Director of PV in the event of problems relating to internal staff workload that may affect the quality and functioning of the tasks being undertaken.
Acts as line manager of assigned staff.
Responsible for recruitment of new staff in PV Department.
Ensures all departmental CVs, job descriptions and training records are complete and up to date and as per corporate policies.
Assists with or generates and reviews proposals and costing for pharmacovigilance business.
Train and mentor PV department staff, as needed.
Ensures training compliance by PV staff at all times.
Represents PV department during for-cause/maintenance client audits or regulatory authority inspections.
Review of Safety Data Exchange Agreements (SDEA)
Education Details:
Master of Pharmacy, Kakatiya University
oPharmacotherapeutics, Drug Toxicity Management and Information Services, Clinical Pharmacy, Community Pharmacy, Clinical Pharmacology
TECHNICAL SKILLS:
ARGUS, ARISg, MedDRA, WHO-DD, Microsoft Office
PROFESSIONAL EXPERIENCE
1) Navatio Pharma, GA Feb 2021-Present
Designation: Sr Pharmacovigilance Scientist
Lead the planning and preparation and review of aggregate safety reports (PADER, PSUR/PBRER and DSUR) and Canadian annual safety reports (ASR) including establishing timelines and content, project management, safety database report requests, review data and author designate detections of such reports.
Review of the risk management plan
Review of safety data, following up with health care reports of AE reports
Attended and participate in meetings and mentored junior Patient Safety Operations associates.
Reviewed labeling documents such as the CCDS, Summary of Product Characteristic (SMPC), Investigator’s Brochure, Canadian Product Monograph, and United States Package Insert (USPI) etc. Reviewed PV agreements to effectively communicate with Safety Systems regarding rules for reporting.
As Author Contributes to developing new regulatory procedures and SOPs
Knowledge on regulatory guidance related to drug safety (FDA and EMA)
Generate line listing from safety data base.
Subject mater expert for setting the PV/regulatory process, PV trainings and building the team to deliverables.
Liaise with internal stake holders such as QA team for audits and inspections.
Authoring of safety data exchange reports (SDEA)
2) Client: Novitium Pharma, NJ
Designation: Safety Operation Led May 2019-Jan 2021
Ensures effective functioning of all PV projects in compliance with client agreement, contract, and local and global regulatory guidelines.
Responsible for quality management, workload management, compliance management and document management across all PV projects.
Manages project and resource allocation within the PV department. Monitors workload of department and alerts the Director of PV in the event of problems relating to internal staff workload that may affect the quality and functioning of the tasks being undertaken.
Acts as line manager of assigned staff.
Client Relationship Management:
Continuously works with internal and external clients to ensure satisfaction.
Invoicing and Budgeting:
Ensures monthly invoices are generated and shared for all PV clients on regular/monthly basis.
Identifies out-of-scope activities and liaise with PV Project Lead and internal departments to initiate and process change orders.
Provides clarification and/or resolve PV invoicing issues.
Ensures pharmacovigilance aspects of projects are managed in line with budgets and agreed timelines to achieve client satisfaction.
Train and mentor PV department staff, as needed.
Always ensures training compliance by PV staff.
Constantly works towards identification of new training and development opportunities for the PV department.
Represents PV department during for-cause/maintenance client audits or regulatory authority inspections.
Represents PV department during pre-qualification client audits.
Generates and reviews departmental SOPs and Working Procedures.
Review of aggregate safety reports (PADER and PSUR/PBRER)
Review of SDEAs
Review of Project management Plan (PMP)
3) Client Name: Aurobindo Pharma, NJ
Sr Manager -Pharmacovigilance Duration: May 2018 to Apr 2019
Responsibilities
Maintain PV expertise and understanding of international safety regulations and guidelines.
Communicate project/product teams, with external partners, HCPs, and Health Authorities, and during internal and external negotiations.
Provide strategic and proactive safety input into development plans
Lead aggregate safety data review activities and coordinate safety surveillance activities
Participate in safety governance process, including presentation of safety analyses
Regulatory compliance - Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed
Review of PSURs, PBRER, RMPs and safety signals
Provides clarification and/or resolve PV invoicing issues.
Ensures pharmacovigilance aspects of projects are managed in line with budgets and agreed timelines to achieve client satisfaction.
Assists with or generates and reviews proposals and costings for pharmacovigilance business.
4) Client Name: Larus Pharma
Manager-PV-Operations Duration: Feb 2016 to Apr 2018
ROLES AND RESPONSIBILITIES IN THE PRESENT JOB
Set up Pharmacovigilance activities (Database, SOPs and Quality systems)
Review and approval of standard operating procedures (SOPs)
Review of PBRER, PSUR, PADER and Addendum to Clinical Overview’s report and RMP Updates
Quality Review of the regulatory documents before they are sent to the client for review.
Take part in the daily management of the PV function.
Monitor compliance with regulations, PV agreements and internal SOPs.
Plan, organize, and manage daily work to meet service level timelines and deliverables.
Handling queries received from regulatory audits.
Provide support to internal or external audits, and during PV regulatory inspections.
Prepare and review Signal Evaluation Reports
5) Client Name: Valent Pharma/Bausch Health, USA
Designation: Senior Aggregate Reporting associate
Duration: From: Dec 2014 to Feb 2016
Support roles involved in creation of Annual Safety Reports (ASRs) (i.e. PSURs, PBRER’s, Addendum to Clinical Overview’s, DSURS and RMP Updates
Lead Trainer and subject matter expert for Aggregate department
Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template
Compile the safety data into the relevant sections of periodic reports such as PBRER and PSUR according to the client.
Reviews and identify the literature that is selected for inclusion in the regulatory document that may lead to the signal detection.
Create all documents in accordance to all applicable SOPs, and convention of the client.
Plan, organize, and manage daily work to meet service level timelines and deliverables.
Work with the Aggregate Reporting lead to escalate issues or tasks outside the normal scope of work.
Provide word and PDF versions of the final signed documents to the client.
Participate in internal and external audits and inspections by clients and health authorities.
Signal detection and Analysis from Line listings
As Quality Reviewer:
•Quality Review of the regulatory documents before they are sent to the client for review.
•To share defects, provide feedbacks to the Team.
•To ensure Turnaround time (TAT) amp; quality standards are met by the team
PROFESSIONAL EXPERIENCE
6) Client name: Pfizer
Designation: Pharmacovigilance Executive
From: Feb 2012 to Dec 2014
Writing of Aggregated Safety Reports (PSUR) and PBRER
Preparation of PSURs, PBRER, summary reports, Addendum Clinical overview reports and Line listings to affiliates.
Collection and Update of worldwide authorization status
Literature search
Characterization of risks (Identified risk, potential risks, missing information)
Collection of Regulatory information, Patient exposure, Clinical studies data (BA/BE studies) and other information from Affiliates/Departments and Units.
Currently handling EU, Row countries, Australia and Brazil periodic safety reports and South Africa and Canada Annual PSURs.
Assessment reports/RMPs/Regulatory recommendations/Regulatory Actions or Signals notified through regulatory Authority site search (PARAC recommendations)
Preparation of Risk Management plans
Prepare and review Signal Evaluation Reports
Client Name: Novartis Pharma
Duration: From: Feb 2011 to 08 Feb 2012.
Designation: Safety Processing Expert
Responsible for processing (i.e., narrative writing, seriousness, causality, and expectedness assessment) and evaluating safety reports originating from clinical studies literature and the post-marketing experience for client-specific products.
Ensure the timely and accurate completion of case processing due diligence activities.
Performing literature review for identification of case reports and other relevant safety information.
Ensure the timely and accurate completion of reconciliation activities.
Assist in the reconciliation of clinical and safety databases.
Participates in project-specific internal teleconferences/meetings and client-specific teleconferences/meetings for operations.
Responsible for the timely completion of safety reports for distribution to Health Authorities, clients, and client’s partners.
oData migration
Assisted in completing manual data migration and electronic data migration, including acceptance, data entry, and quality review.
Performing an extensive quality review of migrated cases.
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