Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
<Enter your own>
Timeline
Generic
Sandip Gorde

Sandip Gorde

Pune

Summary

A resourceful and motivated professional with more than 17 years of experience, including 9 years of recent experience in the medical devices and combination products space (clinical evaluations, risk management, combination products deliverables). Previous experience included primarily in pharmacovigilance case processing and writing periodic, aggregate, and ad hoc reports (regulatory requests and internal signal assessment reports), medical devices PSUR, and oncology injectables production.

Overview

19
19
years of professional experience

Work History

Medical Manager – GMAIST

Pfizer Products India Pvt. Ltd
Mumbai
01.2020 - Current
  • Create and/or update existing CERs, CEPs, PMCF reports, PMS plans, and PMSRs; review and QC of reports authored by colleagues.
  • Clinical literature searches for subject devices, similar or equivalent devices, and literature searches for SOTA for the CER deliverable.
  • Searching literature databases, internal and external repositories, to support the Hazard Analysis and the benefit-risk of Pfizer products.
  • Collect, appraise, and analyze clinical data pertaining to MDCPs from Pfizer safety data, complaints, literature, and prepare summaries for inclusion in the reports.
  • External vigilance databases search for MDCPs.
  • Support on assigned tasks for the MDCP deliverables, with attention to detail, and partner with cross-functional stakeholders.
  • Support to DHF with inputs to hazard analysis (HA), and preparation of the medical rationale document (MRD) for combination products.
  • Test and adopt the best-suited process optimization tools that result in time and cost savings, and improvements in quality.
  • Compliance to TAT, gap assessment, and proactive resolutions.
  • Team Lead (Acting): In addition to the above responsibilities, I have been acting as a team leader for the RMF conversion project for the past year. Activities included resource allocation per the requests, tracking the progress of the deliverables, review of the MDCP deliverables prior to submission, coordination with the POC, and preparation of monthly metrics for combination products deliverables.

Lead Medical Writer

Sciformix Technologies Pvt. Ltd
Pune
01.2018 - 01.2020
  • Author PMSRs for Class I medical devices and combination products.
  • Author PBRERs, HHEs, Ad Hoc Reports, supporting labeling documents for consumer products, and HHEs as per client Standard Operating Procedure and Work Instruction.
  • Conduct literature searches, and screen publications and safety database cases to include in the report.
  • Interaction with clients and other stakeholders.
  • Sharing regular process updates and knowledge with the team.
  • Act as a writing mentor.
  • Coordinate activities related to various types of report writing across a team of writers.
  • Liaise with the client, and act as the primary point of contact for all report-writing activities.

Senior Medical Writer

Sciformix Technologies Pvt. Ltd
Pune
06.2016 - 12.2017
  • Write and review various safety reports (or parts of such reports) for global regulatory submissions for clients, including Periodic Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, and ad hoc reports.
  • Report to the manager on performance, status, and any escalations.
  • Efficiency in preparing search strings and conducting literature searches for authoring various types of reports.
  • Perform a peer review of the reports.
  • Internal and external (client) communication and coordination to get the required inputs.
  • Implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables.
  • Ensure compliance of operations with governing regulatory requirements.
  • Create, maintain, and assume accountability for a culture of high customer service.

Medical Writer

Siro Clinpharm
Thane
06.2014 - 05.2016
  • Draft DSUR/SUSAR for innovative products in accordance with documented guidelines, SOPs, and timelines.
  • Perform a quality check and/or review of DSUR/SUSAR LLs.
  • Ensure that documents are approved and issued as per timelines, and comply with established standards and performance metrics.
  • Work effectively with other writers, communicating project information in a timely manner.
  • Ensure prompt issue escalations to the line manager or project manager.

Clinical Safety Scientist

Cognizant Technology Solutions
Mumbai
04.2012 - 06.2014
  • Author PSURs and ARs for innovative products as per client SOPs and WIs.
  • Organize or attend the kick-off meeting for the allocated Periodic Safety Update Report (PBRER format) or AR.
  • Review PSURs and ARs as per client SOPs and WIs.
  • Capture of quality data for metrics reporting.
  • Ensure the completeness and accuracy of the source documents provided by the client for PSUR and AR.
  • Schedule meetings with client POCs to resolve report-related queries. Regular client interaction for process harmonization.
  • Report to the manager on performance, status, and any escalations.
  • Ensure all the records and documents are maintained according to organizational requirements.
  • Provide resolution to issues that may arise during the case QC review process, and suggest process improvements (changes and implementations).
  • Assess adverse event reports for seriousness, causality, and expectedness, as per the Investigator Brochure, Basic Prescribing Information, or US package insert, consulting the Medical Safety Expert whenever required.
  • Determine the necessity for follow-up, and prepare a follow-up request as needed.
  • Quality review to make the case report complete for the final review and submission.

Drug Safety Associate/Junior Data Analyst

Cognizant Technology Solutions
Mumbai
04.2010 - 03.2012
  • Book in, full data entry, narrative writing, medical event coding, product coding, and self-check of the online QC tool.
  • Receive information on adverse events, perform initial checks, search the database to prevent duplicate entries, create a case file, and initialize received drug safety reports in the safety database.
  • Ensure scientific rigor through accurate, complete, and consistent data entry of adverse event reports from source documents, with an emphasis on timeliness and quality.
  • Use medical dictionaries and business guidelines to code medical history, drugs, and adverse event terms.
  • Identify clinically relevant information missing from the case report, and facilitate its collection by preparing a follow-up request, as needed.
  • Medical judgment, scientific assessment, narrative, labeling, expectedness, and causality assessment.

Production officer

Oncocare India Pvt. Ltd (Oncology Division of Cipla)
Goa
07.2006 - 06.2009
  • I worked as a project team member in the sterile line set-up project at Cipla Goa, Oncology Division.
  • Set up of the Steam sterilizer (FEDEGARI), its software UAT, qualification, SAT, and validation.
  • Documentation of all the tests and handover to the department.
  • Preparation of qualification documents, validation reports, annual product review/product quality reports, and SOPs in the department, and presentation of the monthly production report.
  • Ensure proper adherence and compliance with the SOP on the premises.
  • Implementation of modifications and rectifications in houses.
  • Inspections/Audit visits faced as a production officer: US FDA, WHO, MHRA, TGA, Brazil, FDA.

Education

Certification Course - Leadership in Medical Affairs

GMDP Academy
New York, USA
12-2024

Certification Course - Medical Affairs in Medicines Development

IFAPP Academy & King’s College London
New York, USA
03-2023

Post Graduate Diploma - CLINICAL DATA MANAGEMENT

CREMA
Mumbai
03-2010

Bachelors Degree - Pharmacy

Pravara Rural College of Pharmacy-Pune University
Maharashtra
06-2005

Skills

  • Regulatory compliance
  • Literature research
  • Project management
  • Cross-functional collaboration

Accomplishments

  • Nominated as Employee of the month on numerous times.
  • Was rewarded with 'Above and beyond, the performance award' by the client.
  • Scholarship from 'SIR RATAN TATA Trust' in 2005 for success in the academics.

Languages

  • English
  • Hindi
  • Marathi

<Enter your own>

  • Date of Birth: 01/11/84
  • Gender: Male
  • Marital Status: Married

Timeline

Medical Manager – GMAIST

Pfizer Products India Pvt. Ltd
01.2020 - Current

Lead Medical Writer

Sciformix Technologies Pvt. Ltd
01.2018 - 01.2020

Senior Medical Writer

Sciformix Technologies Pvt. Ltd
06.2016 - 12.2017

Medical Writer

Siro Clinpharm
06.2014 - 05.2016

Clinical Safety Scientist

Cognizant Technology Solutions
04.2012 - 06.2014

Drug Safety Associate/Junior Data Analyst

Cognizant Technology Solutions
04.2010 - 03.2012

Production officer

Oncocare India Pvt. Ltd (Oncology Division of Cipla)
07.2006 - 06.2009

Certification Course - Leadership in Medical Affairs

GMDP Academy

Certification Course - Medical Affairs in Medicines Development

IFAPP Academy & King’s College London

Post Graduate Diploma - CLINICAL DATA MANAGEMENT

CREMA

Bachelors Degree - Pharmacy

Pravara Rural College of Pharmacy-Pune University
Sandip Gorde