Pooja Solanki
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Pooja Solanki Email & Phone Number

Deputy Manager - Medical Writing at BD
Location: Surat, Gujarat, India 4 work roles 2 schools
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Current company
BD
Role
Deputy Manager - Medical Writing
Location
Surat, Gujarat, India
Company size
43782 employees

Who is Pooja Solanki? Overview

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Quick answer

Pooja Solanki is listed as Deputy Manager - Medical Writing at BD, a company with 43782 employees, based in Surat, Gujarat, India. AeroLeads shows a matched LinkedIn profile for Pooja Solanki.

Pooja Solanki previously worked as Senior Associate - Scientific Writing at Indegene and Clinical Regulatory Writer at Meril Life Sciences India Pvt Ltd. Pooja Solanki holds M.S. Pharm, Medical Devices, Gold Medalist In Masters Program. from National Institute Of Pharmaceutical Education And Research - Ahmedabad.

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BD

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Profile bio

About Pooja Solanki

Pooja is a postgraduate in Pharmaceutical Sciences (Medical Devices) and a graduate in Pharmacy. She has about 8 years of clinical regulatory writing experience, of which 6+ years involved writing in the medical device industry. Her experience includes the creation of technical master file (TMFs)/design dossiers, literature search protocols and reports, clinical study reports (CSRs), clinical evaluation plans (CEPs), clinical evaluation reports (CERs), post-market clinical follow-up (PMCF), a summary of safety & clinical performance (SSCPs), periodic safety update reports (PSURs), and other technical and clinical documents.She is proficient in MS Word and Excel applications, has worked on databases such as Embase, PubMed, EndNote, and has excellent communication, and documentation skills. She is self-motivated.

Listed skills include Powerpoint, Hplc, Pharmaceutical Research, Gmp, and 16 others.

Current workplace

Pooja Solanki's current company

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BD
Bd
Deputy Manager - Medical Writing
Surat, GJ, IN
Website
bd.com
Employees
43782
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4 roles

Pooja Solanki work experience

A career timeline built from the work history available for this profile.

Deputy Manager - Medical Writing

Bd

Surat, GJ, IN

Senior Associate - Scientific Writing

Indegene

Bengaluru, Karnataka, India

  • To develop literature search and review protocols.
  • Author end to end CSRs, SSCPs, IBs, CEPs, CERs, PMCFER, and various other clinical regulatory documents with specific focus on sections that require critical analysis and summarization of device safety and performance.
  • Perform gap analysis for medical device technical documents and prepare a list of pending assets.
  • Perform peer review for various regulatory documents and technical review of CEPs, CERs, CSRs, and other… Show more
  • Perform peer review for various regulatory documents and technical review of CEPs, CERs, CSRs, and other regulatory documents.
  • Evaluate client review comments, if necessary, and communicate reviewer feedback to the project manager to ensure consistency in the data presented. Show less
Aug 2021 - Oct 2024

Clinical Regulatory Writer

Meril Life Sciences India Pvt Ltd

Vapi

  • Experienced in drafting literature search protocols, screening of scientific literature, and summarizing clinical data.
  • Responsible for drafting Protocols, ISRs, CSRs, CEPs, CERs, literature search protocols and reports, SSCPs, PMCF protocol, and PMCF report for various range of medical devices.
  • Supported clinical operation & medical writing teams for design, development and documentation of clinical study data.
  • Participated in external audits: CE, ISO, CMDCAS audit for… Show more
  • Participated in external audits: CE, ISO, CMDCAS audit for cardiovascular devices registration and surveillance.
  • Combined understanding of scientific and research methodology, medical device regulations and guidelines and product knowledge to support regulatory affairs submissions for CE marking of new devices and renewal of CE.
Mar 2017 - Aug 2021

Executive - Regulatory Affairs

Envision Scientific

Surat, Gujarat, India

  • Responsible for coordination & preparation of regulatory submissions, renewal submission, variation preparation submission for cardiovascular devices.
  • Prepare, submit & manage final product files submissions (Design Dossier) and communicate effectively with regulatory authorities to obtain timely product approvals
  • Possess good knowledge of Medical Device regulations in European Union Countries (MEDDEV & MDR 745/2017)
  • Coordinated with European Representatives for regulatory… Show more
  • Coordinated with European Representatives for regulatory requirements specific to the medical devices
  • Responsible for preparation and submission of Technical File for CE Certification Application
Jun 2015 - Feb 2017
Team & coworkers

Colleagues at BD

Other employees you can reach at bd.com. View company contacts for 43782 employees →

FF F.A Fahmida Asma F.A Fahmida Asma Colleague at BdDhaka, Bangladesh, Bangladesh View → BS Bruno Saviana Bruno Saviana Colleague at BdLa Teste-de-Buch, Nouvelle-Aquitaine, France, France View → QD Qi Ding Qi Ding Colleague at BdPudong, Shanghai, China, China View → JA Jose Angel Plaza Olivarria Jose Angel Plaza Olivarria Colleague at BdNogales, Sonora, Mexico, Mexico View → RF Ryan Fang Ryan Fang Colleague at BdTaiwan, Taiwan, Province Of China View → MJ Marek Jakubiak Marek Jakubiak Colleague at BdPoland, Poland View → SM Shirley Mahoney Shirley Mahoney Colleague at BdSan Antonio, Texas, United States, United States View → RC Richard Cale, Pharmd Richard Cale, Pharmd Colleague at BdClaremont, California, United States, United States View → DV Denna Villarama Denna Villarama Colleague at BdSan Diego, California, United States, United States View → VR Vanessa Rocha Vanessa Rocha Colleague at BdSão Paulo, São Paulo, Brazil, Brazil View →
2 education records

Pooja Solanki education

FAQ

Frequently asked questions about Pooja Solanki

Quick answers generated from the profile data available on this page.

What company does Pooja Solanki work for?

Pooja Solanki works for BD.

What is Pooja Solanki's role at BD?

Pooja Solanki is listed as Deputy Manager - Medical Writing at BD.

Where is Pooja Solanki based?

Pooja Solanki is based in Surat, Gujarat, India while working with BD.

What companies has Pooja Solanki worked for?

Pooja Solanki has worked for Bd, Indegene, Meril Life Sciences India Pvt Ltd, and Envision Scientific.

Who are Pooja Solanki's colleagues at BD?

Pooja Solanki's colleagues at BD include F.A Fahmida Asma, Bruno Saviana, Qi Ding, Jose Angel Plaza Olivarria, and Ryan Fang.

How can I contact Pooja Solanki?

You can use AeroLeads to view verified contact signals for Pooja Solanki at BD, including work email, phone, and LinkedIn data when available.

What schools did Pooja Solanki attend?

Pooja Solanki holds M.S. Pharm, Medical Devices, Gold Medalist In Masters Program. from National Institute Of Pharmaceutical Education And Research - Ahmedabad.

What skills is Pooja Solanki known for?

Pooja Solanki is listed with skills including Powerpoint, Hplc, Pharmaceutical Research, Gmp, Clinical Research, Regulatory Affairs, Standard Operating Procedure, and Life Sciences.

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