Pharmaceutical Industry Specialist, Life Science Domain,
Aktualisiert am 22.01.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 22.01.2024
Verfügbar zu: 100%
davon vor Ort: 100%
Life science domain
Good Pharmacovigilance Practice
Data Entry Specialist
MS Office
Pharmacovigilance
Quality control
Quality Management
Good Clinical Practice
Good Manufacturing Practice
Pharmacy
Standard Operating Procedures
Clinical Trial
Microsoft Excel
Microsoft word
Organization Skills
Good Communication
Microsoft office
Microsoft outlook
MedDRA
Clinical Research Associate
English
Verhandlungssicher
German
A2
Hindi
Muttersprache
Marathi
Fortgeschritten

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

1 year 8 months
2020-11 - 2022-06

Managing the in-scope drug safety activities

Information Process Enabler. Life Sciences ? PATIENT SAFETY SPECIALIST MedDRA Pharmacovigilance Data entry ...
Information Process Enabler. Life Sciences ? PATIENT SAFETY SPECIALIST

Managing the in-scope drug safety activities for Client products including processing of Individual case safety reports and their medical review. Creation of periodic safety reports, management activities and reporting and publishing of safety documents in compliance with the patient safety regulations.

  • Maintain a log of source documents and other communications. Case intake, duplicate check and registration using the Sapphire database (using Sapphire database for case handling).
  • Performed Data entry, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case.
  • After three months of work was promoted to Perform Quality Review for the cases.
  • Assisting reconciliation, driving case close closure, coordinating translations and ensuring reports are sent to the customer within deadlines.
  • Identified potential product complaints to forward and perform all appropriate coding and write case narratives for adverse events.
  • Attended project team meetings and provided feedback on any Challenges/issues or successes.


Role Description:

Worked in Covid-19 Vaccine project for AstraZeneca (Sapphire database). The purpose of this position was to provide effective service to client Pharma Company, to help them comply with Pharmacovigilance regulatory responsibility of Individual case safety reporting.

MedDRA Pharmacovigilance Data entry ICH-GCP guidelines (International Conference on Harmonization- Good Clinical Practice) PSUR Clinical Research Clinical Trial Handling of Individual Case safety reporting (ICSRs) Narrative writing GCP Adverse drug reaction (ADR) Adverse event (AE) Analytical techniques (Physical chemical methods HPLC HPTLC TLC Chromatography etc.) GMP Pharmaceuticals Risk Management Theoretical knowledge of Regulatory affairs Quality Management CAPA MedDRA. Good Communication skills Sapphire (database of case handling) AZ clinical Dictionary Medical Dictionary for regulatory activities. MS Office MS Word Power point Excel Internet Basics
Pharmacovigilance
India

Aus- und Weiterbildung

2 years 4 months
2018-08 - 2020-11

Master of Pharmacy

Master (Final grade: A+), University of Pune, MGV?s Pharmacy College, Panchavati, Nashik, MH, India
Master (Final grade: A+)
University of Pune, MGV?s Pharmacy College, Panchavati, Nashik, MH, India
3 years 11 months
2014-06 - 2018-04

Bachelor of Pharmacy

Bachelor, University of Pune, MGV?s Pharmacy College, Panchavati, Nashik, MH, India
Bachelor
University of Pune, MGV?s Pharmacy College, Panchavati, Nashik, MH, India
1 month
2014-04 - 2014-04

Higher Secondary School

12th standard, Bhonsala Military College, Nashik, MH, India
12th standard
Bhonsala Military College, Nashik, MH, India
1 month
2012-04 - 2012-04

Secondary School

10th standard, St. Patrick Convent high School, Nashik, MH, India
10th standard
St. Patrick Convent high School, Nashik, MH, India

Kompetenzen

Top-Skills

Life science domain Good Pharmacovigilance Practice Data Entry Specialist MS Office Pharmacovigilance Quality control Quality Management Good Clinical Practice Good Manufacturing Practice Pharmacy Standard Operating Procedures Clinical Trial Microsoft Excel Microsoft word Organization Skills Good Communication Microsoft office Microsoft outlook MedDRA Clinical Research Associate

Produkte / Standards / Erfahrungen / Methoden

PROFILE

  • 1 year and 8 months of experience in Pharmacovigilance department in life science domain as an Information process Enabler - Patient safety specialist.
  • Worked at Tata Consultancy Services (Mumbai, India) in Covid-19 Vaccine project for Astra Zeneca (Nov2020 to Jun-2022).
  • Completed Master of Pharmacy in Pharmaceutical Quality Assurance department from Savitribai Phule Pune University, MH, India in Year 2020.
  • I have outstanding communications skills, efficient time management skills, ability to hit goals within time frame with quality, quick learner and ability to adapt new situations.
  • I have German class B driving licence.
  • I can speak German language upto level A2 and English language fluently.


MASTER OF PHARMACY PROJECT DETAILS:

Formulation, Development and Evaluation of Fast Dissolving Tablet of Amisulpride using Cocrystallization technique.

  • Amisulpride is a poorly aqueous- soluble drug. Co-crystallization technique has been used here to increase its solubility. Sodium acetate was used as co-former for the formation of Co-crystals.
  • Hence Amisulpride drug which was poorly soluble can be formulated as fast dissolving using Co-crystallization technique.


Tools

Sapphire (database of case handling), AZ clinical Dictionary, Medical Dictionary for regulatory activities.


Computer skills

MS Office, MS Word, Power point, Excel, Internet Basics.


Technical skills

ICH-GCP guidelines (International Conference on HarmonizationGood Clinical Practice), PSUR, Clinical Research, Clinical Trial, MedDRA, Pharmacovigilance, Handling of Individual Case safety reporting (ICSRs), Narrative writing, GCP, Adverse drug reaction (ADR), Adverse event (AE), Analytical techniques (Physical, chemical methods, HPLC, HPTLC, TLC, Chromatography, etc.), GMP, Pharmaceuticals, Risk Management, Theoretical knowledge of Regulatory affairs, Quality Management, CAPA, MedDRA.

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