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jobs
Drug safety scientist
Grace Olokpa
,
Milton Keynes, United Kingdom
Experience
Other titles
Skills
I'm offering
Experienced drug safety scientist
Markets
United Kingdom
Language
English
Fluently
Ready for
Ongoing relation / part-time
Available
My experience
2018 - ?
job
Safety Evaluation Scientist
Eisai.
• Have PV scientific responsibility for assigned products (investigational and post marketing) and to act as a PV expert, providing advice and expertise to others.
• Undertaking routine signal detection and evaluation activities in conjunction with the GSOs, including the review of literature.
• Playing an active role in the production of PSURs, DSURs and risk management plans and in the creation of 6MLL.
• Contributing to investigator brochures and protocols, where required.
• Working in collaboration with the GSOs and assist with producing accurate responses to safety related questions arising from regulatory authorities, DSMBs and ethics committees.
• Building effective working relationships and participate as a member of cross functional project related activities.
• Using appropriate sources of information to prepare Business Objects searches to retrieve relevant data and listings for aggregated Safety Reports and ad hoc safety requests.
• Contributing to process improvements and prepares and reviews SOP's and Working Practices, as required.
• Undertaking routine signal detection and evaluation activities in conjunction with the GSOs, including the review of literature.
• Playing an active role in the production of PSURs, DSURs and risk management plans and in the creation of 6MLL.
• Contributing to investigator brochures and protocols, where required.
• Working in collaboration with the GSOs and assist with producing accurate responses to safety related questions arising from regulatory authorities, DSMBs and ethics committees.
• Building effective working relationships and participate as a member of cross functional project related activities.
• Using appropriate sources of information to prepare Business Objects searches to retrieve relevant data and listings for aggregated Safety Reports and ad hoc safety requests.
• Contributing to process improvements and prepares and reviews SOP's and Working Practices, as required.
Marketing, Risk Management, Management, Safety, Regulatory, Production
2017 - 2018
job
Drug Safety Specialist
Eisai.
• Ensured all ICSRs relating to EMEA products are processed from receipt to submission, in accordance with timelines and standards specified in internal controlled documents.
• Entered source data onto the global safety database (ARISg) and performing quality checks of ICSRs.
• Submitted and distributed ICSRs to regulatory agencies, Eisai affiliate offices and partners in accordance with regulatory and company requirements and timelines.
• Undertook and participated in training relating to ICSR processing, quality and compliance.
• Assisted with the maintenance of ICSR documentation.
• Maintained the EEL PV mailbox.
• Supported the EEL PV Safety Evaluation Team in the preparation and quality control of ICSR listings for aggregate safety reports.
• Entered source data onto the global safety database (ARISg) and performing quality checks of ICSRs.
• Submitted and distributed ICSRs to regulatory agencies, Eisai affiliate offices and partners in accordance with regulatory and company requirements and timelines.
• Undertook and participated in training relating to ICSR processing, quality and compliance.
• Assisted with the maintenance of ICSR documentation.
• Maintained the EEL PV mailbox.
• Supported the EEL PV Safety Evaluation Team in the preparation and quality control of ICSR listings for aggregate safety reports.
Training, Database, Compliance, Affiliate, Safety, Regulatory, Performing, Processing
2015 - 2016
job
Junior Drug Safety Specialist
Novartis Pharmaceuticals.
• Evaluated, coordinated and entered adverse event reports to ensure accurate, complete and consistent data entry and processed from source documents with emphasis on timelines and quality.
• Assisted in the daily workload allocation.
• Determined the necessity for follow up and prepared follow up as required by local SOP.
• Received calls from Novartis representatives, healthcare professionals and patients reporting adverse events and paid close attention to detail when recording information provided.
• Played an active leading role in cross -functional teams on safety matters/DS&E special projects relating to investigational and marketed drugs.
• Performed expediting activities of individual case report and periodic safety report.
• Worked with Clinical Safety Scientists, Group Heads and Medical Safety Physician to ensure reports were accurately evaluated and databased.
• Reviewed Phase IV Clinical Trial, PMS protocol, and POP programmes.
• Ensured Serious Adverse Event and Post Marketing Adverse events were evaluated accurately within the required timeframes.
• Carried out reconciliation activities.
• Supported the Medical Safety Physicians/Medical Adviser/Medical Director with project activities in specific therapeutic areas, compatibly with timely quality checks of individual case reports and regulatory periodic reports.
• Assisted the Medical Safety Physicians/Medical Adviser/Medical Director in monitoring the safety profile of product by raising attention issues or signals.
• Provided support as required for regulatory authority inspections audits.
• Assisted in the daily workload allocation.
• Determined the necessity for follow up and prepared follow up as required by local SOP.
• Received calls from Novartis representatives, healthcare professionals and patients reporting adverse events and paid close attention to detail when recording information provided.
• Played an active leading role in cross -functional teams on safety matters/DS&E special projects relating to investigational and marketed drugs.
• Performed expediting activities of individual case report and periodic safety report.
• Worked with Clinical Safety Scientists, Group Heads and Medical Safety Physician to ensure reports were accurately evaluated and databased.
• Reviewed Phase IV Clinical Trial, PMS protocol, and POP programmes.
• Ensured Serious Adverse Event and Post Marketing Adverse events were evaluated accurately within the required timeframes.
• Carried out reconciliation activities.
• Supported the Medical Safety Physicians/Medical Adviser/Medical Director with project activities in specific therapeutic areas, compatibly with timely quality checks of individual case reports and regulatory periodic reports.
• Assisted the Medical Safety Physicians/Medical Adviser/Medical Director in monitoring the safety profile of product by raising attention issues or signals.
• Provided support as required for regulatory authority inspections audits.
Marketing, Event, Support, Monitoring, Safety, Regulatory, Detail, UP
My education
2013
-
2017
University of Surrey
BSc, Biomedical Sciences
BSc, Biomedical Sciences
2011
-
2013
n/a
Doctorate, Biology, Chemistry, and Physics
Doctorate, Biology, Chemistry, and Physics
2003
-
2009
Our Lady of Mercy Secondary School
Secondary, N/a
Secondary, N/a
Croydon College
BTEC Level 3, N/a
BTEC Level 3, N/a
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