Shravan Anapurapu
Bengaluru
Summary
Reliable professional with experience in Process and Compliance, Quality, pharmacovigilance, Drug Safety and operational processes. Proven ability to manage multiple projects and prioritize tasks to meet deadlines.
Overview
12
12
years of professional experience
Work History
Safety Science Assistant Manager
Fortrea Drug Development (Formely Labcorp and Covance)
04.2019 - Current
- Oversee audit and GxP inspection preparedness and conduct pre-audit/inspection dipsticks and Good Manufacturing Practices (GMP) with PV involvement such as Good Clinical Practices (GCP)
- Attended PSS qualification and in-flight study audits as needed
- Mentor/train new hires and perform periodic retraining as possible
- Conduct Periodic Independent Quality and Compliance project reviews and support effective closure of identified issues/gaps
- Manage departmental Quality issues, CAPA development & implementation (inclusive of internal QEs and those resulting from audits & inspections)
- Support review/update of departmental process guidance documents (SOPs, WIs, job aids, templates etc)
- Support development of responses and CAPA plans for audit and inspection findings
- Perform impact assessment and trending analysis for Quality & compliance and communicate area of risk to PV and Quality Management
- Support preparation of Departmental compliance dashboards and associated actions
- Initiate, implement and monitor process improvement and departmental compliance initiatives.
Safety Process Specialist
Fortrea Drug Development (Formely Labcorp and Covance)
04.2021 - 09.2022
- Actively Support Audit & Inspection preparedness and pre-audit dipsticks
- Support periodic Quality and compliance Reviews and preparation of required dashboards
- Support achieving departmental training compliance metrics
- Support Internal Quality Issue Management in Veeva QMS and CAPA implementation
- Support development and update of process guidance documents (SOPs, WIs, job aids, templates etc)
- Support compliance with Veeva QMS timelines for all internal issues.
Lead Safety Science Specialist
Fortrea Drug Development (Formely Labcorp and Covance)
04.2019 - 03.2021
- Assist with overall Clinical Safety and/or PV & DSS operations associated with products including the entire adverse event process which may include safety data collected from clinical trials and/or post marketing settings (i.e Unsolicited reports)
- Manage and process expedited adverse events to required standard and submit them to client and regulatory agencies (if required) within agreed/stated timelines
- Post holder is responsible for providing this service to clients either as support function to client project groups or as standalone business
- Manage receipt and processing of all adverse event reports reported either spontaneously from any source or from clinical trial
- May execute routine quality review of AE reports for other members of group ensuring that case processing and data quality meet global regulatory compliance
- Monitor workflow for assigned studies/programs to ensure all deadlines are met
- Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed
- Preparation of electronic trail master file (eTMF) Quality review of clinical trial cases
- Preparation of responses to queries received from Regulatory Authorities
- Monitoring daily workflow and making sure do not miss any regulatory due cases
- Maintaining quality/error matrix for entire project.
Safety Associate III
Syneos Health
06.2015 - 04.2019
- Data entry which includes intake, Book-in, Coding (using MedDRA, CDD and WHODD), Narrative writing, letter generation/FU
- Manage receipt and processing of all adverse event reports reported spontaneous from any source from clinical trial
- Conducting daily huddles, updating team for updates, conducting training Reconciliation of cases received/letter sends Taking care of urgent queries raised by team
- Mentoring and give training to new joiners
- Ensure all records and documents are maintained as per organizational requirements
- Triage and classify incoming events; prioritize cases according to regulatory and project requirements
- Be responsible in meeting timelines and quality standards
- Ensure integrity and completeness of data according to applicable regulations and guidelines, SOPs and project-specific guidelines
- Create complete, accurate, clear and concise narratives adhering to established project template
- Data entry, identifying suspected drugs, concomitant medications, past drug events and medical history and performing validation
- Safety narrative writing of Non-serious spontaneous and Literature-spontaneous reports.
Senior Associate Drug Safety
Tech Mahindra
06.2012 - 06.2015
- Duplicate search to prevent duplicate entries in database and perform appropriate case follow-up, generating and requesting follow-up letters
- Case book-in, case processing from source document and AEM forms
- Confirms case validity, seriousness, event term selection, coding of adverse events using MedDRA, suspect products, concomitant medications, lab investigations and overall consistency of information
- Identify case assessment related problems and reviewed reports, and Identify potential product complaints
- Narrative writing for ICSRs
- Handled various cases like spontaneous and legal documents which include Claim Letter, Summons and Complaint, Plaintiff Fact Sheet and Medical Records.
Education
Master of Science - Formulation Science
University of Greenwich
United Kingdom01.2010
Bachelor of Pharmacy - Pharmacy
Kakatiya University
Warangal06.2008
Skills
- Argus Safety Database 10 years
- Veeva Quality 04 years
- Audit and inspection preparedness 03 years
- CAPA Development and implementation 03 Years
Personal Information
Title: Safety Science Assistant Manager (Process and Compliance team)
Languages
English
Bilingual or Proficient (C2)
Telugu
Bilingual or Proficient (C2)
Hindi
Upper intermediate (B2)
Timeline
Safety Process Specialist
Fortrea Drug Development (Formely Labcorp and Covance)
04.2021 - 09.2022
Safety Science Assistant Manager
Fortrea Drug Development (Formely Labcorp and Covance)
04.2019 - Current
Lead Safety Science Specialist
Fortrea Drug Development (Formely Labcorp and Covance)
04.2019 - 03.2021
Safety Associate III
Syneos Health
06.2015 - 04.2019
Senior Associate Drug Safety
Tech Mahindra
06.2012 - 06.2015
Master of Science - Formulation Science
University of Greenwich
Bachelor of Pharmacy - Pharmacy
Kakatiya University
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