freiberufler Specialist- Technical Writer for Medical Devices auf freelance.de

Specialist- Technical Writer for Medical Devices

zuletzt online vor 6 Tagen
  • 12€/Stunde
  • 500060 Hyderabad
  • Weltweit
  • en  |  hi  |  de
  • 23.03.2021

Kurzvorstellung

I am a quality-oriented professional who has been consistently praised as diligent by my co-workers and management. Over the course of 10 year career, I’ve developed a diverse skill set in the field of pharmaco-devicevigilance & medical writing.

Ich biete

  • Medical Writing
  • Regulatory Affairs Management
  • Technische Dokumentation

Projekt‐ & Berufserfahrung

Specialist-Technical Writing (Festanstellung)
Kundenname anonymisiert, Mumbai
1/2021 – offen (4 Monate)
Life Sciences
Tätigkeitszeitraum

1/2021 – offen

Tätigkeitsbeschreibung

-Responsible for writing Clinical Evaluation Plans, Clinical Evaluation Reports, Creation of SSR reports.
-Ensures the CER and SSR files are linked to appropriate Quality Systems and Regulatory documents
-Support and act as SME during audits and inspections
-Actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.

Eingesetzte Qualifikationen

Medical Writing

Manager-Pharmacovigilance & Medical Affairs (Festanstellung)
Kundenname anonymisiert, Mumbai
12/2019 – 12/2020 (1 Jahr, 1 Monat)
Life Sciences
Tätigkeitszeitraum

12/2019 – 12/2020

Tätigkeitsbeschreibung

- Initiate and manage the Pharmacovigilance activity of the Company encompassing all the plants
- Liaison with European and African development agencies, for technical support and to create visibility for Africure
- Manage Medical Affairs activities

Eingesetzte Qualifikationen

Medical Writing, Pharmazie

Technical/Regulatory Lead (Festanstellung)
Kundenname anonymisiert, Chennai
1/2019 – 12/2019 (1 Jahr)
Healthcare
Tätigkeitszeitraum

1/2019 – 12/2019

Tätigkeitsbeschreibung

-Lead projects involving Clinical Evaluation Reports, PSURs, RMP, PMS plans.
-Literature Database (PubMed, Embase, Ovid) & Regulatory Database Search (MHRA, Swissmedic, BfArM, FDA MAUDE, FDA Recall) handling

Eingesetzte Qualifikationen

Medical Writing

Pharmacovigilance Quality and Compliance Expert (Festanstellung)
Kundenname anonymisiert, Hyderabad
1/2018 – 12/2018 (1 Jahr)
Life Sciences
Tätigkeitszeitraum

1/2018 – 12/2018

Tätigkeitsbeschreibung

Lead projects to enhance the methodologies and processes used to monitor and improve safety case and aggregate report quality and compliance. Lead the preparation and maintenance of manuals and other documents related to quality and compliance monitoring. Ensure safety cases and aggregate reports meet global Health Authority requirements and Company quality standards.
Contribute to projects aimed at optimizing methodologies and processes to monitor safety cases and aggregate reports compliance and quality. Ensure compliance to
i) safety information exchange commitments in Pharmacovigilance Agreements with global license partners
ii) Health Authority submission requirements (ICSRs and aggregate reports) and
iii) Novartis internal timelines for safety case databasing and aggregate report production through:
•Compiling and analyzing compliance data
•Leading the investigation in to the root cause(s) for late transfers/late submissions
•Performing trend analyses of the results of the root cause analysis
•Collaborating with process owners and other SMEs to develop and implement CAPAs and, post implementation, verify the effectiveness of these.
•Communicating/escalating compliance issues to the Pharmacovigilance Compliance and Quality Management and Patient Safety Alliance teams
•Preparing reports / presentations on compliance for CMO&PS management
Perform reconciliation of safety information exchanged with global license partners to confirm completeness, investigation in to any gaps identified and completion of remedial actions.

Eingesetzte Qualifikationen

Pharmaforschung

Pharmacovigilance Scientist (Festanstellung)
Kundenname anonymisiert, Hyderabad
9/2016 – 1/2018 (1 Jahr, 5 Monate)
Life Sciences
Tätigkeitszeitraum

9/2016 – 1/2018

Tätigkeitsbeschreibung

1. Evaluation and Quality Review of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on accuracy, timeliness and quality.2. Assess adverse event reports for seriousness, causality and expectedness as per the Investigator Brochure/Basic Prescribing Information/US package insert, collaborating with Medical Safety Expert.3. Determine the necessity for follow-up and prepare follow-up requests and targeted check-lists.4. Drive process changes according to internal and external drivers.5. Act as Subject Matter Expert during audits & inspections and develop Corrective and Preventive Actions and measure effectiveness. Support QA in creating and handling of deviations and exception requests. 6. Develop, monitor process related metrics and timely release of monitoring reports. 7. Support in creating and maintaining the PSMF.

Eingesetzte Qualifikationen

Pharmaforschung, Windows 7, MS Office (Anwenderkenntnisse)

Safety Processing Expert (Festanstellung)
Kundenname anonymisiert, Hyderabad
1/2012 – 3/2014 (2 Jahre, 3 Monate)
Life Sciences
Tätigkeitszeitraum

1/2012 – 3/2014

Tätigkeitsbeschreibung

Facilitates safety monitoring by optimizing scientific quality documentation and data entry of Safety case reports for Company drugs.
• Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timelines and quality.
• Assist with related administrative and procedural activities, training and mentoring other Safety Processing associates.
• Support Safety Projects or database validation activities as required.
• Support writing activities- aggregate reports, standard operating procedures, process related documents and product guidance documents.

Eingesetzte Qualifikationen

Pharmazie

Zertifikate

Project Management Professional Certification Training by Simplilearn
Dezember 2017

Ausbildung

Master of Pharmacy
(2011)
Jahr: 2011
Ort: Ranchi, India
Bachelor of Pharmacy
(2009)
Jahr: 2009
Ort: Hyderabad, India

Qualifikationen

Master of Pharmacy in Clinical Research with 8.5 years of experience in Patient Safety, Drug-Device Vigilance and Medical Writing.

Über mich

ICSR handling, QC & QA, Medical Device Regulation, MEDDEV, ISO-13485, ISO-14155, Subject Matter Expert, Audit Support and Training.

Persönliche Daten

Sprache
  • Englisch (Fließend)
  • Hindi (Muttersprache)
  • Deutsch (Grundkenntnisse)
Reisebereitschaft
Weltweit
Profilaufrufe
1034
Alter
33
Berufserfahrung
10 Jahre (seit 04/2011)
Projektleitung
5 Jahre

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