Professional Summary
Overview
Work History
Education
Skills
Accomplishments
Interests
Certification
LANGUAGES
Timeline

Sayali Hadke

Sci-Edge Abstracts
Pune
Sayali Hadke
1
Certification
7
years of professional experience

Scientific Curator & clinical Writing Professional with 6+ years of experience in scientific literature analysis, patent research, and pharmaceutical data extraction. Expertise in interpreting Scientific, clinical information and techno-legal patent content. Skilled in Research Analysis, Medical Writing, Regulatory Writing, Literature Review, Patent Documentation, Pharmacovigilance, and Clinical Data Management, with working knowledge of ICH-GCP and drug safety processes. M.Pharm with strong academic credentials (GPAT AIR 210, NIPER JEE AIR 560). Certified in Clinical Research Management (A+) and Intellectual Property Rights (DCIPRL). Proven ability to transform complex scientific data into structured, high-quality content for regulatory and research applications. Seeking opportunities in Medical Writing, Reseach analyst, Market Research, Clinical Writing, Patent Analysis, and Clinical Research. Immediate joiner | Open to on-site/remote opportunities.

Work History

Scientific Curator

6 Years 11 Months
Sci-Edge Abstracts | 04.2019 - 03.2026
  • Executed comprehensive analysis of published literature to identify key concepts related to molecular structures and reaction schemes.
  • Optimized data entry processes for global databases, enhancing researchers' ability to access scientific information.
  • Oversaw thorough data reviews to pinpoint deficiencies, inaccuracies, and incompatibilities, improving final output analysis.
  • Utilized specialized databases, including SciFinder STN and DailyMed, to extract strategic information for pharmaceuticals and life sciences.
  • Directed cross-functional teams in conducting evidence-based research analysis to enhance R&D and knowledge management initiatives.
  • Directed data integrity initiatives and ensured compliance with established standards in scientific data management.
  • Executed comprehensive evaluations and interpretations of data to ensure drug safety and regulatory compliance.
  • Oversaw abstraction processes for pre- and post-marketing data across various pharmaceutical therapeutic areas.
  • Conducted critical analysis of data regarding adverse events, drug interactions, and contraindications to enhance risk assessment processes.
  • Conducted quality analysis of abstracted information to identify errors and ensure data accuracy.

Drug Safety- Pharmacovigilance, Adverse Event Reporting

1 Year 1 Month
Dysmech Competency Services Pvt. Ltd | 06.2023 - 07.2024
  • E-Internship
  • Responsible for monitoring, assessing, documenting, and reporting adverse events (AEs), serious adverse events (SAEs), and other safety information related to pharmaceutical products to ensure patient safety and regulatory compliance.

CRC/CRA

1 Month
Dysmech Competency Services Pvt. Ltd | 03.2023 - 04.2023
  • E-Internship
  • as Clinical Research Coordinator (CRC) responsible for coordinating and managing clinical trials at research sites, hospitals, or healthcare institutions.
  • Ensures that studies are conducted according to the protocol, regulatory requirements, ethical guidelines, and sponsor expectations while safeguarding participant safety and data quality.
  • as Clinical Research Associate (CRA) monitors clinical trials on behalf of sponsors, CROs, or pharmaceutical companies to ensure study sites comply with protocols, regulatory requirements, and Good Clinical Practice (GCP).

Education

M. Pharm. - Pharmaceutics

M. V. P. Samaj's College of Pharmacy | Nashik | 06-2018
  • Thesis Paper: [Formulate, optimize & evaluate solid dispersion tablets of praziquantel using novel carriers such as kolliphor p 407, kolliphor p 188, kolliphor HS15, kolliphor GMS II, Solupus.]
  • Melt agglomeration technique is used to formulate solid dispersion.
  • 8.940 GPA/CGPA

PGDM

Advanced Diploma in Clinical Research Management | 04-2023
  • Final Grade: A+

PGDM - Intellectual Property Rights Law (DCIPRL)

M. V. P.'s Law College | Nashik | 06-2018

Bachelor of Pharmacy

PES's Modern College of Pharmacy (for Ladies) | Moshi, Pune | 06-2015
  • Final Grade: 65%
  • Thesis Paper: Simultaneous of Metformin, Glimepiride and Rosiglitazone in lab. Mixture by Linear Combination

Skills

Symyx Draw
SciFinder
ChemDraw
PubMed
Database management
Scientific Writing
Medical Writing
Clinical Data Management
Literature search
Medidata Rave EDC
Oracle Clinical
Clintrial
Argus Safety
Microsoft Excel
MS word
Google sheet
Patent Analysis
Patent Searching
Regulatory Writing
Scientific DocumentationData Validation
Data Quality Control
Data Review
Data Reconciliation
Database Searching
Content Classification
Veeva Vault

Accomplishments

  • Awarded as "Star award" in 2024 in recognition of analysis of highest number of documents and consistent performance in quality and quantity in IntiPALS. (2024)
  • A Masters in Pharmaceuticals with 8.940 CGPA score and AIR 210 in GPAT and AIR 560 in NIPER JEE.

Interests

Clinical data management
Medical writing
Regulatory affairs
Clinical research Associate
Clinical research coordinator
Database management
Pharmacovigilance
Market research
Patent analyst
Scientific writing
Medical reviewer
Medical summarizer
Scientific curator

Certification

Successfully Completed Advanced Diploma in Clinical Research Management (10/2022 - 04/2023) Management with A+ grade learn Clinical data management, Pharmacovigilance, CRA, CRC, Medical writing, Regulatory affairs

LANGUAGES

English Professional Working Proficiency
Marathi
Hindi Professional Working Proficiency

Timeline

Drug Safety- Pharmacovigilance, Adverse Event Reporting

Dysmech Competency Services Pvt. Ltd
06.2023 - 07.2024Read More

CRC/CRA

Dysmech Competency Services Pvt. Ltd
03.2023 - 04.2023Read More

Scientific Curator

Sci-Edge Abstracts
04.2019 - 03.2026Read More

M. V. P. Samaj's College of Pharmacy

M. Pharm. from Pharmaceutics
Read More

Advanced Diploma in Clinical Research Management

PGDM
Read More

M. V. P.'s Law College

PGDM from Intellectual Property Rights Law (DCIPRL)
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PES's Modern College of Pharmacy (for Ladies)

Bachelor of Pharmacy
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Sayali Hadke