01/05/2024 updated
SB
partially available
info: Available evenings and weekends
Senior Research Associate, Lead Engineer, Research Assistant
India
Only remote
MPharm - PharmacologyBiocompatibilityDatabasesPharmacologyRaw DataRisk AnalysisToxicologyRegulatory Affairs
databases, MS Access, MS Excel, MS PowerPoint, MS Word, raw data, Toxicology, Biocompatibility, ECHA, Pubchem, Pharmacology, Gap assessment, Toxicological risk assessment, regulatory affairs.
Experience
Professional experience5 - 10 years
Freelancer since2024
Languages
EnglishFluent
Project history
Role Description:
- Review reports on Health Based Exposure Limits such as PDE, OEL, ADI for various
chemicals.
- Conducting scientific literature searches to gather, analyze, and compile relevant scientific data
from diverse clinical and non-clinical safety, and efficacy databases.
- Evaluating the quality, producing data summaries, and drawing conclusions for various
toxicological endpoints such as systemic toxicity, genotoxicity, skin/eye irritation,
sensitization, carcinogenicity, reproductive toxicity, developmental toxicity and toxicokinetic,
in accordance with guidelines established by OECD, ICH & EPA.
- Drafting environmental and ecotoxicity assessments pertaining to chemicals specifically
addressing factors like persistence, bioaccumulation and toxicity.
- Reviewing and authoring hazard or safety assessments for various chemical products such as
pharmaceuticals, cosmetics, nutraceuticals, agrochemicals, botanicals and biomedical devices.
- Writing and submitting hazard or safety documentation in compliance with various regulations
such as EU, EPA, ICH or FDA.
- Review reports on Health Based Exposure Limits such as PDE, OEL, ADI for various
chemicals.
- Conducting scientific literature searches to gather, analyze, and compile relevant scientific data
from diverse clinical and non-clinical safety, and efficacy databases.
- Evaluating the quality, producing data summaries, and drawing conclusions for various
toxicological endpoints such as systemic toxicity, genotoxicity, skin/eye irritation,
sensitization, carcinogenicity, reproductive toxicity, developmental toxicity and toxicokinetic,
in accordance with guidelines established by OECD, ICH & EPA.
- Drafting environmental and ecotoxicity assessments pertaining to chemicals specifically
addressing factors like persistence, bioaccumulation and toxicity.
- Reviewing and authoring hazard or safety assessments for various chemical products such as
pharmaceuticals, cosmetics, nutraceuticals, agrochemicals, botanicals and biomedical devices.
- Writing and submitting hazard or safety documentation in compliance with various regulations
such as EU, EPA, ICH or FDA.
Role Description:
- Provides biological safety assessment to achieve ISO 10993 compliance and to support product
development activities.
- Assessing the biological safety impact of manufacturing and supplier changes on patient
contacting devices.
- Creating product-specific testing plans, including recommended biological testing per ISO
10993 and justifications.
- Analyze and interpret biological test results.
- Review and maintain existing biocompatibility evaluations for current products.
- Develop and execute experimental testing protocols to support the biocompatibility
characterization of materials and products.
- Author for preparing BEP & BER.
- Drafting Toxicological risk assessment for the medical devices.
- Knowledge of the risk assessment paradigm (i.e, hazard identification, exposure assessment,
dose-response and risk characterization).
- Helping develop and generate material for staff training and data presentations.
- Supports in Audits, Inspections, quality management system and project management.
- Determination of Tolerable Intake and Tolerable Exposure, MOS for chemicals that leach from
medical devices as per ISO 10993-17.
- Supports in complaint investigations, CAPA's and other general technical support duties within
the team.
- Provides biological safety assessment to achieve ISO 10993 compliance and to support product
development activities.
- Assessing the biological safety impact of manufacturing and supplier changes on patient
contacting devices.
- Creating product-specific testing plans, including recommended biological testing per ISO
10993 and justifications.
- Analyze and interpret biological test results.
- Review and maintain existing biocompatibility evaluations for current products.
- Develop and execute experimental testing protocols to support the biocompatibility
characterization of materials and products.
- Author for preparing BEP & BER.
- Drafting Toxicological risk assessment for the medical devices.
- Knowledge of the risk assessment paradigm (i.e, hazard identification, exposure assessment,
dose-response and risk characterization).
- Helping develop and generate material for staff training and data presentations.
- Supports in Audits, Inspections, quality management system and project management.
- Determination of Tolerable Intake and Tolerable Exposure, MOS for chemicals that leach from
medical devices as per ISO 10993-17.
- Supports in complaint investigations, CAPA's and other general technical support duties within
the team.