Identify and select cases from a workflow, determining appropriate prioritization criteria and submission dates
Ensure compliance with process requirements by reviewing the coding of suspect drugs using the Company Drug Dictionary and WHO Drug Dictionary
Review the coding of concomitant drugs, treatment drugs, and past drugs using the WHO Drug Dictionary
Code adverse events, indications of suspect and concomitant medications, medical history, and laboratory investigations according to coding conventions
Write narratives in a chronological format and perform quality checks of cases before reporting to regulatory authorities
Mentor and train Drug Safety Associates and Drug Safety Coordinators
Label events according to the Company Core Data Sheet
Improved workplace safety by conducting regular inspections and identifying potential hazards
Mitocon Biopharma, India
1 year 1 month
2019-08 - 2020-08
Processing of safety data
Safety Associate Trainee
Safety Associate Trainee
Process safety data according to applicable regulations, guidelines, standard operating procedures (SOPs), and project requirements
Perform pharmacovigilance activities per project requirements, including but not limited to collecting and tracking incoming Adverse Events (AEs)/ endpoint information
Determine the initial/update status of incoming events and enter them into the database
Code AEs and products, write narratives, and perform literature-related activities
Assume other workflow responsibilities for the assigned project as directed by an operations team member or manager
Ensure meeting the expected productivity and quality standards
Identify quality problems, if any, and bring them to the attention of a senior team member or mentor
Ability to identify quality problems, if any, and bring them to the attention of a senior team member/ mentor
Mitocon Biopharma, India
1 year 2 months
2012-05 - 2013-06
Quality Control
QC Chemist
QC Chemist
Conduct daily analysis of raw materials, in-process, intermediate, and API samples
Perform daily verification and calibration of analytical balance, pH meter, KF, LOD, ROI, NVM, SOR, IR, and viscosity measurements
Possess knowledge of cGMP related to the Quality Control department
Conduct stability and holding time studies, and handle reference standards and the qualification of working standards
Responsible for sampling in-process and finished products
HPLC, GC ?CALIBRATION, TROUBLESHOOTING
Enhanced product quality by conducting thorough chemical analysis and implementing rigorous testing protocols
Derex Labs, india
Aus- und Weiterbildung
Aus- und Weiterbildung
2018 Study - Pharmacovigilance/ Clinical Research, Medical Writing, CDMS CliniIndia, India Degree:
Diploma
2012 Study - Biotechnology/ Biology, Bio Informatics Andhra University, India Degree: Master in Biotechnology
Profil To achieve excellence as a dynamic professional by utilizing my analytical abilities and quest for knowledge to the fullest for the growth of the organization and to grow along with it. I seek a challenging position in a well-established company that offers professional growth and ample opportunities to learn and enhance my competencies. I am an effective communicator with exceptional teamwork skills, strong problem-solving abilities, and excellent data collection and analytical skills.
Einsatzorte
Einsatzorte
Ingelheim am Rhein (+50km)
Deutschland
möglich
Projekte
Projekte
2 years 2 months
2020-09 - 2022-10
Prioritization criteria and submission dates
Safety Associate 1
Safety Associate 1
Identify and select cases from a workflow, determining appropriate prioritization criteria and submission dates
Ensure compliance with process requirements by reviewing the coding of suspect drugs using the Company Drug Dictionary and WHO Drug Dictionary
Review the coding of concomitant drugs, treatment drugs, and past drugs using the WHO Drug Dictionary
Code adverse events, indications of suspect and concomitant medications, medical history, and laboratory investigations according to coding conventions
Write narratives in a chronological format and perform quality checks of cases before reporting to regulatory authorities
Mentor and train Drug Safety Associates and Drug Safety Coordinators
Label events according to the Company Core Data Sheet
Improved workplace safety by conducting regular inspections and identifying potential hazards
Mitocon Biopharma, India
1 year 1 month
2019-08 - 2020-08
Processing of safety data
Safety Associate Trainee
Safety Associate Trainee
Process safety data according to applicable regulations, guidelines, standard operating procedures (SOPs), and project requirements
Perform pharmacovigilance activities per project requirements, including but not limited to collecting and tracking incoming Adverse Events (AEs)/ endpoint information
Determine the initial/update status of incoming events and enter them into the database
Code AEs and products, write narratives, and perform literature-related activities
Assume other workflow responsibilities for the assigned project as directed by an operations team member or manager
Ensure meeting the expected productivity and quality standards
Identify quality problems, if any, and bring them to the attention of a senior team member or mentor
Ability to identify quality problems, if any, and bring them to the attention of a senior team member/ mentor
Mitocon Biopharma, India
1 year 2 months
2012-05 - 2013-06
Quality Control
QC Chemist
QC Chemist
Conduct daily analysis of raw materials, in-process, intermediate, and API samples
Perform daily verification and calibration of analytical balance, pH meter, KF, LOD, ROI, NVM, SOR, IR, and viscosity measurements
Possess knowledge of cGMP related to the Quality Control department
Conduct stability and holding time studies, and handle reference standards and the qualification of working standards
Responsible for sampling in-process and finished products
HPLC, GC ?CALIBRATION, TROUBLESHOOTING
Enhanced product quality by conducting thorough chemical analysis and implementing rigorous testing protocols
Derex Labs, india
Aus- und Weiterbildung
Aus- und Weiterbildung
2018 Study - Pharmacovigilance/ Clinical Research, Medical Writing, CDMS CliniIndia, India Degree:
Diploma
2012 Study - Biotechnology/ Biology, Bio Informatics Andhra University, India Degree: Master in Biotechnology
Profil To achieve excellence as a dynamic professional by utilizing my analytical abilities and quest for knowledge to the fullest for the growth of the organization and to grow along with it. I seek a challenging position in a well-established company that offers professional growth and ample opportunities to learn and enhance my competencies. I am an effective communicator with exceptional teamwork skills, strong problem-solving abilities, and excellent data collection and analytical skills.
Vertrauen Sie auf Randstad
Im Bereich Freelancing
Im Bereich Arbeitnehmerüberlassung / Personalvermittlung