SAIKRISHNA P
Senior Medical writer (CSR Writing)
Perupalem
Summary
An astute professional with 9+ years of diversified experience in authoring and reviewing various regulatory/submission documents, looking for a new opportunity.
Overview
10
10
years of professional experience
7
7
years of post-secondary education
1
1
Certification
Work History
Specialist
Tata Elxsi
Pune
08.2023 - Current
- Authoring and reviewing CSRs in compliance with the ICH E3 guidelines and protocols in compliance with ICH E6 guidelines for various regulatory authorities.
- Authoring of clinical development plans and protocol synopsis.
- Authoring and review of submission documents and IB updates.
Senior Medical Writer
ClinChoice
Hyderabad
12.2021 - 05.2023
- Authoring and reviewing CSRs, in compliance with the ICH E3 guidelines and protocols in compliance with ICH E6 guidelines for various regulatory authorities.
- Authoring of clinical development plans and protocol synopsis.
- Authoring and review of Submission documents and IB updates.
- Participated in a Workshop at Manila, Philippines (Feb-2023) for Project Improvement
- Elicit information about current processes, uncover potential problems and propose improvement actions
Lead Engineer (Medical Writing)
HCL Technologies
Bangalore
02.2019 - 11.2021
- Authoring and reviewing CSRs in compliance with the ICH E3 guidelines and protocols in compliance with ICH E6 guidelines for various regulatory authorities.
- Assisting new writers in drafting the regulatory documents.
- Responsible for Clinical evaluation writing/updating the CERs in compliance with MEDDEV 2.7.1, Rev 4 and EU MDR 2017/745
- Experience and skill performing comprehensive literature searches (PubMed, Google scholar, EMBASE, Ovid)
- Literature screening for post-market surveillance activities as needed (e.g., customer surveys, Post-marketing follow-up, vigilance/MDR complaints/), systematic literature reviews (e.g., Screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
Senior Drug Safety Associate (Level III)
Bioclinica Safety and Regulatory Solutions
Mysore
09.2016 - 06.2018
- Carried out various Aggregate Reports: Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Safety Update Reports (PSUR)
- As summarized above I have worked on various types of aggregate reports, of which PBRER is one of my most experienced reports which I have ever drafted in my short span
- As a literature review specialist: Ensure effective and accurate collection, review of local/global literature report and reporting of literature searches and conducted to determine regional reportability
- Ensure quality of literature ICSR's reporting and entering into safety database
- Quality Review: Confirms case validity, event term selection and coding
- Confirms/assesses event seriousness and coding of products
- Performs listedness assessment and seriousness assessment
- Perform a quality check, which includes verifying certain fields determined as critical, including but not limited to reportability, as well as conformity to E2B standards
- Initiate Suspected Unexpected Serious Adverse Reaction (SUSAR) process via notification to client and routing of the case back to client for processing
- Determine whether additional queries through the DSU are needed at this stage and document them in the global safety database with a brief description of the information needed
- Adverse event reports processed from clinical, solicited, spontaneous, medical devices, MLM, Eudravigilance and from literature sources
- As a narrative writer: Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields
Pharmacovigilance Scientist (PVS I)
Tata Consultancy Services (TCS)
Mumbai
12.2014 - 08.2016
- Serious Adverse Event (SAE) and Non-Serious Adverse Event Report Processing
- Processing SUSAR cases in clinical studies, strictly compliant to 7-Day and 15-Day timelines
- MedDRA coding and Narrative writing, processing different cases like E2B, legal and literature cases
- Adverse event coding by MedDRA browser and drug coding by WHO-DD browser, working on Argus safety database, Coding events, indications and patient history based on MedDRA
Education
B. Pharmacy - Pharmacy
Shri Vishnu College of Pharmacy Andhra University
Bhimavaram 01.2010 - 05.2014
High School Diploma -
Sri Chaitanya Junior College
01.2008 - 05.2010
Skills
- Clinical Study Reports (CSRs)
- CSR Safety narratives
- Clinical Study Protocols and ICFs
- IB updates
- CTD modules
- PSURs, PBRERs, and DSURs
- Clinical Evaluation Reports (CERs)
- MDR and MDD Remediation
- Literature Review and Data Analysis
- Expert in writing Literature summaries
- Pharmacovigilance: Adverse Event Reporting and Management
- Safety Database Management (Argus and Arisg)
Accomplishments
- Participated in a Workshop at Manila, Philippines (Feb-2023) from my team for Project Improvement.
- Received accolades for exceptional attention to detail and high-quality deliverables in Tata Elxsi 2024.
- Best Employee Award from from TCS in 2016, Bioclinica 2018 and Tata Elxsi in 2024.
Personal Information
- Age: 32
- Father's Name: Penugonda Srinivasa Venkata Subbarao
- Date of Birth: 08/10/92
Certification
ICH GCP Certificate. MDR Certification from TUV Notified Body.
Timeline
Specialist
Tata Elxsi
08.2023 - Current
Senior Medical Writer
ClinChoice
12.2021 - 05.2023
Lead Engineer (Medical Writing)
HCL Technologies
02.2019 - 11.2021
Senior Drug Safety Associate (Level III)
Bioclinica Safety and Regulatory Solutions
09.2016 - 06.2018
ICH GCP Certificate. MDR Certification from TUV Notified Body.
07-2016
Pharmacovigilance Scientist (PVS I)
Tata Consultancy Services (TCS)
12.2014 - 08.2016
B. Pharmacy - Pharmacy
Shri Vishnu College of Pharmacy Andhra University
01.2010 - 05.2014
High School Diploma -
Sri Chaitanya Junior College
01.2008 - 05.2010
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