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Senior drug safety associate with strong case processing experience, sae reconciliation, knowledge of safety regulations
Jennifer Obih
,
Stevenage, United Kingdom
Experience
Other titles
Skills
I'm offering
Clinical experience across phases 1-4 (oncology,cardiology).
QC of cases, generating queries.
Use of EDC and eTMF systems.
Safety database experience (argus, Oracle AERS, ARISg)
QC of cases, generating queries.
Use of EDC and eTMF systems.
Safety database experience (argus, Oracle AERS, ARISg)
Markets
United Kingdom
Links for more
Once you have created a company account and a job, you can access the profiles links.
Language
English
Fluently
Ready for
Larger project
Full time contractor
Available
My experience
2019 - ?
job
Senior Associate, Pharmacovigilance
Worldwide Clinical Trials.
Reviewing incoming SAE data for completeness and accuracy.
Performing data entry in the safety database and/or complete applicable tracking of incoming safety information.
Generating queries for missing or unclear information and follow up with sites for resolution
Authoring safety management plan for assigned studies
Attending meetings, client meetings and investigator meetings as appropriate
Presenting at investigator meetings as required
Performing QC of SAEs processed by other PV associates
Generating regulatory reports and performing safety submissions as needed
Preparing and submitting periodic safety reports as needed
Maintaining knowledge and understanding of safety related regulations and guidelines
Maintaining basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope
Assisting with bid defenses or other presentations as required
Mentoring or training new PV staff as needed
Performing data entry in the safety database and/or complete applicable tracking of incoming safety information.
Generating queries for missing or unclear information and follow up with sites for resolution
Authoring safety management plan for assigned studies
Attending meetings, client meetings and investigator meetings as appropriate
Presenting at investigator meetings as required
Performing QC of SAEs processed by other PV associates
Generating regulatory reports and performing safety submissions as needed
Preparing and submitting periodic safety reports as needed
Maintaining knowledge and understanding of safety related regulations and guidelines
Maintaining basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope
Assisting with bid defenses or other presentations as required
Mentoring or training new PV staff as needed
Narrative writing, Data entry, Case management, Query management, Training, Sae reconciliation, Safety submissions, HP QC
2016 - 2019
job
Pharmacovigilance Scientist Level 2
Covance.
Apr 2016 to June 2019
• Maintain awareness of, and compliance with, regulations and timelines associated with reporting SAEs to Regulatory Authorities, Ethics Committees and Investigators.
• Entering information into relevant study database or tracker, perform data entry, narrative writing and manual coding.
• Performing query follow up, tracking, document QC and filing.
• Training and mentoring of Level 1 Associates.
• Supporting with SAE reconciliation and collection of regulatory information.
• Assisting with submission of expedited reports and associated tracking.
• Maintain awareness of, and compliance with, regulations and timelines associated with reporting SAEs to Regulatory Authorities, Ethics Committees and Investigators.
• Entering information into relevant study database or tracker, perform data entry, narrative writing and manual coding.
• Performing query follow up, tracking, document QC and filing.
• Training and mentoring of Level 1 Associates.
• Supporting with SAE reconciliation and collection of regulatory information.
• Assisting with submission of expedited reports and associated tracking.
Writing, Training, Database, Mentoring, Compliance, Regulatory, Pharmacovigilance, QC, Performing, UP
2015 - 2016
job
Safety Co-ordinator
unknown.
• Monitoring Safety Intake eFax account or equivalent for incoming AE and SAE reports.
• Entering report information for all faxed reports into the Safety Intake log.
• Assisting SO with project start up activities, study maintenance and archiving of project documents at study end.
• Providing acknowledgement of receipt to reporter of AE and forwarding AE/SAE report to appropriate SO.
• Assists SO with generation and tracking of follow-up queries, as directed by the SO.
• Entering report information for all faxed reports into the Safety Intake log.
• Assisting SO with project start up activities, study maintenance and archiving of project documents at study end.
• Providing acknowledgement of receipt to reporter of AE and forwarding AE/SAE report to appropriate SO.
• Assists SO with generation and tracking of follow-up queries, as directed by the SO.
Monitoring, Safety, UP
2014 - 2015
job
Clinical Trials Administrator
Xention.
• Reading, understanding and applying Xention's SOPs as related to clinical activities.
• Setting up and maintaining clinical trial master files and master product development file (MPDF).
• Communicating effectively with project team and resource providers; tracking trial progress / key dates.
• Organising and attending project meetings, clinical team meetings; take minutes and getting feedback on the minutes from the attendees.
• Having thorough understanding of outsourced contracts and scope of work, relevant therapeutic areas, protocols and other trial documentation within a project.
• Setting up and maintaining clinical trial master files and master product development file (MPDF).
• Communicating effectively with project team and resource providers; tracking trial progress / key dates.
• Organising and attending project meetings, clinical team meetings; take minutes and getting feedback on the minutes from the attendees.
• Having thorough understanding of outsourced contracts and scope of work, relevant therapeutic areas, protocols and other trial documentation within a project.
Product development, Contracts, Development, Administrator, Contracts, UP
2013 - 2014
job
PV Officer
Diamond Pharma.
• Triaging case reports and logging into safety database and performing full data entry.
• Quality reviewing of XMLs for completeness ensuring no missing data in XML file and processing of legacy cases.
• Tracking and reconciling cases and communication with the client as applicable
• Highlighting areas of concern / discrepancies in the ADR arena to Manager.
• Maintaining an up to date knowledge of pharmacovigilance regulations.
• Quality reviewing of XMLs for completeness ensuring no missing data in XML file and processing of legacy cases.
• Tracking and reconciling cases and communication with the client as applicable
• Highlighting areas of concern / discrepancies in the ADR arena to Manager.
• Maintaining an up to date knowledge of pharmacovigilance regulations.
XML, Database, Safety, Pharmacovigilance, Performing, Processing, Manager, UP
2011 - 2013
job
Safety Specialist
PPD-Clinical Research Organisation.
• Review SAEs for completeness and accuracy, prepare and submit client SAE notifications, send follow up SAE queries to investigator sites, prepare Physician Assessment Form and patient SAE narratives.
• Entering data into Oracle AERS and global SAE tracker, quality check data entered by junior colleagues onto the safety database for completeness and accuracy.
• Identifying any further training needs and performing training as required.
• Preparing and submitting CIOMS report and accompanying letter for expedited events as per expedited reporting plan.
• Attending project team / client meetings for assigned projects and promptly advising Safety Project Lead and Manager of any significant safety and regulatory concerns.
• Assisting in preparation of files for archiving, and transfer to clients at the end of projects.
• Acting as primary safety specialist, deputise and act as back up on other projects; reconciling tasks- Review Data Management listings, database reports and validation checks.
THERAPEUTIC EXPERIENCE
• Oncology:Oncology/Hepatocellular carcinoma Phase 3, 3 years experience
• Cardiology: Atrial fibrillation Phase 3, 18 months experience
• Haemotology, Virology: Blood borne diseases, RSV, Phase 3 and 4,15 months experience
• Entering data into Oracle AERS and global SAE tracker, quality check data entered by junior colleagues onto the safety database for completeness and accuracy.
• Identifying any further training needs and performing training as required.
• Preparing and submitting CIOMS report and accompanying letter for expedited events as per expedited reporting plan.
• Attending project team / client meetings for assigned projects and promptly advising Safety Project Lead and Manager of any significant safety and regulatory concerns.
• Assisting in preparation of files for archiving, and transfer to clients at the end of projects.
• Acting as primary safety specialist, deputise and act as back up on other projects; reconciling tasks- Review Data Management listings, database reports and validation checks.
THERAPEUTIC EXPERIENCE
• Oncology:Oncology/Hepatocellular carcinoma Phase 3, 3 years experience
• Cardiology: Atrial fibrillation Phase 3, 18 months experience
• Haemotology, Virology: Blood borne diseases, RSV, Phase 3 and 4,15 months experience
Oracle, Training, Data management, Database, Management, Regulatory, Safety, Assessment, Performing, Manager, UP
My education
n/a
MSc, Pharmacology
MSc, Pharmacology
n/a
BSc, Biomedical Sciences
BSc, Biomedical Sciences
?
-
2003
Kings College London
Masters, Pharmacology
Masters, Pharmacology
?
-
2002
University of Bradford
Bachelors, Biomedical Sciences
Bachelors, Biomedical Sciences
?
-
2000
University of Greenwich
Bachelors, Biomedical Sciences
Bachelors, Biomedical Sciences
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