Sri Rekha Boddu
Preston,Lancashire
Summary
9 years of experience in Pharmacovigilance. Managed end to end signal management process from calendar preparation to submission of reports including signal detection, validation and assessment. Experienced in ICSR processing (Triage, Book-in, Data entry, medical review and Quality review of ICSRs), drafting of PBRERs and responding to health authority requests, skilled in GVP modules, ICH guidelines and authority databases (Eudravigilance, iDAP, Vigibase, FAERS and Canada Vigilance database)
Overview
9
9
years of professional experience
6
6
years of post-secondary education
Work History
Assistant Manager
Aurobindo Pharma Ltd
Hyderabad, India
12.2017 - 07.2022
- Leading/Managing Signal management team
- Vendor management (allocation of work, WSR, Quality review meetings, process update meetings)
- Management of timeline (allocation of work to submission of reports)
- Maintenance of signal detection calendar and update on regular basis
- Review of the Signal Management Reports (SMR)
- Update all the trackers related to the Signal Management activities
- Detailed literature review relevant to validation reports, assessment reports, PSURs and others as needed
- Generation of Line listings in Argus database for preparation of Aggregate reports
- Drafting of single case reports, validation and assessment reports and health authority requests
- To conduct and coordinate the Safety Review Meetings including documentation assistance as required
- Collection of ongoing signals and safety evaluation from licensing partners for the Products in accordance with SDEA including distribution and communication of such with all licensing partners for the global territories as required
- Provides input on cross-functional ad-hoc requests set up to address urgent and important safety issues
- Support audits, inspections, and CAPA/deviation resolution
- Prepare monthly compliance report and KPI
- Contribute to timely and effective development, revision, implementation, and management of Standard Operating Procedures (SOP) by completing all required activities as assigned
- Trained and mentored team members and vendors
- Worked closely with PSUR/PBRER, ACO, RMP, RMM, Canada Summary reports, ICSR teams (Quality review, medical review of cases in Argus) and Configuration of products in Argus console as per company requirements.
Senior Associate-Drug Safety
Tech Mahindra (Pfizer)
Hyderabad, India
04.2015 - 04.2017
- Monitoring, receipt and tracking Individual Case Safety Reports (ICSRs) and workflow
- Responsible for case triage, data entry, MedDRA coding of events, Narrative writing, case routing, and case lock/closure as per the requirement
- Quality Review of Cases in Pharmacovigilance database (Argus) (Spontaneous, Clinical Trial & Literature)
- Generate follow-up queries when necessary
- Mentoring new joiners
Senior Safety Processing Associate
Accenture Services Pvt. Ltd (Novartis)
Chennai, India
06.2013 - 04.2015
- Receive information on adverse events (AE); perform initial checks, Collation of information relevant to AE and preparation and submission of Individual Case Safety Reports (ICSR) to regulatory authority within stipulated timelines (Spontaneous reports, PMS reports, Literature reports etc.)
- Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality
- Coding of Adverse Events, Medical History and Laboratory Data using MedDRA dictionary
- Writing narratives to summarize details of AE as per Regulatory Guidelines.
- QC checks to ensure Quality and Accuracy of reports as per SLAs
- Adhering to productivity, compliance and quality control.
- Mentor new associates
- Tracking compliance of Serious and Non-Serious cases
- Participate in Client interactions and Telecoms if required.
Education
B.Pharmacy - Pharmacy
08.2006 - 08.2010
M.Pharmacy - Pharmacology
10.2010 - 11.2012
Skills
- End to end PV Case Processing (All types of cases)
- Workflow management
- Team management
- Vendor management
- Signal management reports (detection, validation, assessment)
- Drafting health authority requests
- Aggregate reports ( PBRER/PSUR, RMP, RMM, CASR)
- Products configuration in Argus
- QMS and Compliance monitoring
Languages
English
Fluent
Telugu
Native
Accomplishments
- Received Numero Uno award in Accenture
- Received High Performance Delivered award in Accenture
- Helped many mentees in getting Off QC certification from clients
- Supervised team of 04 members and vendor team of 20 members.
- Improved vendor quality of signal management reports
- Saved several productive hours of time by implementing shortcuts in MS Excel and by using MedDRA app.
- Implemented SMR single case review process
- Published articles in 02 national and 02 international journals
Additional Information
Eligible to work in the UK (Dependent Skilled Worker Visa till Dec 2024)
Timeline
Assistant Manager - Aurobindo Pharma Ltd
12.2017 - 07.2022
Senior Associate-Drug Safety - Tech Mahindra (Pfizer)
04.2015 - 04.2017
Senior Safety Processing Associate - Accenture Services Pvt. Ltd (Novartis)
06.2013 - 04.2015
Dr. M.G.R Medical University - M.Pharmacy, Pharmacology
10.2010 - 11.2012
Dr. M.G.R Medical University - B.Pharmacy, Pharmacy
08.2006 - 08.2010
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