Praveen Kumar Reddy Dareddy
Centerton,AR
Summary
Experienced Pharmacovigilance professional having 9+ years of experience in pharmacovigilance with skills in drug safety, MICC, Aggregate reporting and focused on adverse event reporting of investigational and post-marketed pharmaceutical drugs. Hands-on expertise in start to end of Case Processing (unsolicited, solicited and literature reports) across multiple therapeutic areas. Handle escalation calls from HCPs and consumers. Authoring Aggregate reports including PADERs. Through knowledge of DSUR, PSUR/PBRERs and Signal Detection activities. Proficient in case processing, validity assessment, triaging, duplicate search, Case Book-in, and adverse event (SAE and AE) coding using MedDRA. Responsible to predict resources needed to reach objectives and manage resources in an effective and efficient manner. Good knowledge of US and EU Pharmacovigilance regulatory requirements. Highly organized, motivated and detail oriented. Valued Assistant Project Manager addresses complex obstacles with experienced insight and anticipation. Demonstrates knowledge of quality management principles through clear communication of task expectations and informed suggestions for process optimizations. Determined advocate of safe and ethical work environment for staff to comfortably accomplish project objectives according to organizational standards.
Overview
10
10
years of professional experience
Work History
Associate Project Manager-Drug Safety
Ikcon Pharma Inc (Techsol LifeSciences)
2021.07 - Current
- Responsible for overseeing day-to-day activities of entire team
- Manage and coordinate across PV projects (client specific)
- Monitors Medical Information and Medical Affairs inbox for inquiries
- Perform additional tasks/activities as needed
- Assist in developing and implementing new techniques in PV activities
- Authoring Aggregate reports including PADERs,
- Through knowledge of DSUR, PSUR/PBRER & Signal detection activities.
- Responsible for generating the line listings & summary tabulations for the preparation of Aggregate reporting
- Responsible for collection of Regulatory information, Patient exposure, Clinical studies data and other information from Affiliates across Globe and cross functional units as applicable
- Responsible for getting official confirmation from clients on all project related documents identified in VMP are delivered
- Responsible for obtaining customer feedback using customer satisfaction form
- Execute gap analyses, workshop preparation and delivery, requirements gathering, configuration, validation, and customer training
- Experience in Medical Information Center (MIC)- Requesting follow-up i.e., written or telephone.
- Respond to medical information inquiries from physicians, pharmacists, nurses, and other health care professionals, consumers, and payers.
- Identify adverse events and product complaints during interactions with customers. Perform intake sufficient to generate adverse event and product complaint reports in compliance with MICC and client standard operating procedures.
- Proficient in case processing, validity assessment, triaging, duplicate search, Case Book-in, and adverse event (SAE and AE) coding using MedDRA and narrative writing.
- Monitoring mail box for any MICC queries and addressing them according.
- Provide functional leadership for internal and customer allocated project teams and hold responsibility for ensuring that project timelines are met.
- Mapping clients' requirements and taking initiatives for maximizing client base by maintaining regular contact with key clients.
- Identified and resolved risks to minimize project disruption.
- Developed comprehensive project plans, outlining tasks, timelines, and resources required for successful completion.
Drug Safety Scientist II – Pharmacovigilance
Bioclinica
2019.08 - 2021.06
- Client Management & Issue Resolution
- Overseeing escalations by team members and resolving issues put up by them
- Conducting annual/quarterly/monthly operational review and presentations
- Training & Performance Assessment
- Conducting weekly training sessions for new recruits and existing employees via presentations
- Overseeing performance of individual team members and team while aligning it with company goals
- Other Key Responsibilities
- Regulatory Reporting Mailbox triage and management
- Answer project related queries, filing submission and acknowledgement
- Documents generation of daily assessment reports and sharing it to entire team
- Follow departmental AE workflow procedures
- High level of proficiency in all workflow tasks
- Perform any other drug safety related activities as assigned
- Monitor current incoming cases to meet timelines
- Provide guidance for Triage, Book-in, Data entry & Quality teams.
Senior Drug Safety Associate- Pharmacovigilance
Bioclinica
2017.03 - 2019.08
- As Case Processor (as applicable): Responsible for data entry of Individual case safety reports into ARGUS safety database
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures
- Process all incoming cases to meet timelines
- Full data entry including medical coding and safety narrative as required
- Enter and code, as applicable, case data, including but not limited to: event, seriousness, reported causality (when appropriate), medical history, and laboratory data as provided by reporter
- Code products specified as suspect or concomitant by reporter
- Provide narrative, as required
- Perform peer review of cases after Book-in and Data Entry activities (as applicable): Review Adverse Event (AE) report data for completeness and verify certain fields to determine as critical (including but not limited to reportability) as well as conformity to E2B standards
- Initiate follow-up activities to obtain additional information and clarification, as appropriate
- Forward cases for case review or invalid workflow in global safety database
- Peer-review cases and evaluate for accuracy, consistency, and completeness in safety database against source document
- This includes, but is not limited to, checking consistency of narrative and other data fields, ensuring appropriate follow-up activities have been undertaken (including action items), creation of non-assessed letter for exchange, and ensuring main reason for any delay is entered in routing comment as appropriate
- Correct data entry errors, if any, prior to routing case in global safety database
- Track and document all observations and recommendations on defect tracker
- Handling consumer reports and assessing case validity
- Notify affiliate groups to perform follow up on product complaints and also notify DSU about case amendments
- Assuring and maintaining compliance with regulatory and local/ global SOP timelines using proactive workflow management
- Tracking errors and documenting, sharing them with processors, managers and conducting knowledge sharing sessions
- Conducting team huddles and sharing recent updates with team
- Conducting knowledge tests on monthly basis
- As Medical Coder (as applicable): Responsible for coding all medical history, events, drugs /procedures/indications, and laboratory tests according to appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD).
Senior Associate Analyst- Pharmacovigilance
Pfizer Inc
2015.11 - 2017.03
- Handling consumer reports and assessing case validity
- QC complete case
- Interpretation of non-serious or serious ADRs of spontaneous
- Writing narratives to summarize essential details of case
- Perform labeling, causality and final assessment of case
- Responsible for maintaining 100% training compliance as per client assigned training curriculum
- Evaluates consistency, completeness, accuracy of safety database, tracking database and source document entry forms
- Be responsible in meeting timelines, and quality standards
- Assuring and maintaining compliance with regulatory and local/ global SOP timelines using proactive workflow management
- Tracking errors and documenting, sharing them with processors, managers and conducting knowledge sharing sessions
- Conducting team huddles and sharing recent updates with team.
- Trained and supervised employees on office policies and procedures.
- Collaborated with cross-functional teams to drive successful completion of complex projects within deadlines.
Pharmacovigilance Analyst- Pharmacovigilance
Aurobindo Pharma
2014.05 - 2015.11
- Receive information on adverse events, perform duplicate search and initiate received drug safety report in drug safety database
- Triaging case to prioritize case for expedited reporting in Argus
- Acknowledging receipt of ICSRs to sender within timelines documented in relevant SOP
- Ensure accurate complete and consistent data entry of adverse event reports from source documents report which can be spontaneous, clinical, literature, published reports in origin with emphasis on timelines and quality that includes, seeking medical review and case file archiving
- Coding of medical history and adverse events by using MedDRA
- Responsible for identifying duplicate/invalid ICSRs and handling as per relevant SOP
- Identify missing information which is important for case and raising follow-up requests when required
- Identifying potential SUSAR’s cases and processing them on priority
- Experience in Medical Information Center (MIC)- Requesting follow-up i.e., written or telephone
- Identifying and recording adverse events and product issues and providing excellent client service by delivering high quality results
- Answering and documenting enquiries accurately
- Filling ADE, product complaint and product information forms as per SOPs, writing narratives.
Education
Master of Science - Pharmacology
University of Bedfordshire
Bedfordshire, Luton, UK08.2013
Bachelor - Pharmacy
Ratnam Institute of Pharmacy
Andhra Pradesh, India04.2011
Skills
- Hands on experience on Oracle Argus safety.
- Aggregate Reporting & Signal detection.
- Project management and team handling experience.
- Scope Management
- Client Relationships
- Critical Thinking
- Friendly, Positive Attitude
- Data Entry
- Time Management
- Teamwork and Collaboration
- Self-Directed
Publications Seminars
- National level seminar on Recent trends in pharmaceutical sciences organized by APTI in Ratnam institute of pharmacy Nellore, 5th Sep 2008.
- AICTE sponsored a national conference on Emerging trends in pharmaceutical sciences in MNR College, Sangareddy, 27, 28th Feb. 2009.
- Attended International pharmaceutical congress and a poster has been presented at Manipal University in Mangalore.
- Activity of aerial parts of Flemingia macrophylla presented in 62nd Indian Pharmaceutical Congress 2010 at Manipal University.
Timeline
Associate Project Manager-Drug Safety
Ikcon Pharma Inc (Techsol LifeSciences)
2021.07 - Current
Drug Safety Scientist II – Pharmacovigilance
Bioclinica
2019.08 - 2021.06
Senior Drug Safety Associate- Pharmacovigilance
Bioclinica
2017.03 - 2019.08
Senior Associate Analyst- Pharmacovigilance
Pfizer Inc
2015.11 - 2017.03
Pharmacovigilance Analyst- Pharmacovigilance
Aurobindo Pharma
2014.05 - 2015.11
Master of Science - Pharmacology
University of Bedfordshire
Bachelor - Pharmacy
Ratnam Institute of Pharmacy
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