Drug Safety Public Health Coordinator
3.
8 Quick Apply Temporary Contract 5 hours ago Full Job Description Duties:
Operations Sets work priorities and direction with input from Manager.
Responsible for the accurate and timely book-in and acknowledgement of adverse event information in compliance with applicable Client SOPs and guidelines.
Perform simple queries of the safety database, e.
g.
duplicate searches.
Maintain and manage dept Safety mailbox, distributing to relevant parties as applicable.
May perform initial data entry of ICSRs (review, extract, accurately enter AE data from ICSR reports).
May interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.
Meet specific data and quality targets for case handling Responsible for regulatory submissions of ICSR and aggregate reports.
Assist with tracking and reconciliation of incoming adverse event reports, Investigator letter distribution, and regulatory submissions.
Coordinate submission of product complaints to the Quality assurance department.
Participate in department projects, as required and will be cross-trained to handle other functions as deemed necessary Recognizes situations that require assistance from more senior staff members and seeks assistance from appropriate internal and external resources.
Assists Safety Specialists in sending and tracking follow-up letters.
Remain current with case handling SOPs, guidance documents and database technology Ensures compliance with SDEA and other global regulatory reporting requirements for ICSR May assist manager in the preparation of training material and assist in training new employees their functional area.
May assist manager with writing/reviewing guideines for their functional area of expertise.
May assist with other projects as necessary (i.
e, study unblinding, reconciliation with vendors, etc) Ensures departmental workflow processes and timelines are followed
Qualifications:
Excellent interpersonal communication skills, both written and oral Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).
Safety database and data entry experience preferred Basic understanding of medical and drug terminology preferred Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred Demonstrates initiative, teamwork and accountability Demonstrated success working both independently and in collaboration with others A quality driven individual with strong attention to detail and accuracy is required Strong organizational skills, and ability to adapt to change A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strick timelines is required.
Ability to follow guidelines and procedural documents Operations Sets work priorities and direction with input from Manager.
Review, extract and accurately enter AE data from ICSR reports from both investigational and post marketing products.
Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.
Review, enter, and verify follow-up information for cases and make accurate determination of significant information Performs review of ancillary documentation accompanying ICSR reports and identifies pertinent information for incorporations into the case narrative Correctly identify cases requiring targeted follow-up, determine relevant follow-up required and prepare follow-up queries.
Have solid working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate.
Will interact with other Drug Safety functional areas to process adverse events efficiently and reliably.
Will liaise with clinical department, affiliate, marketing or contract research organizations as needed on safety data issues (i.
e.
, obtaining clarification or follow-up information).
Identifies issues/concerns in a timely and appropriate manner Meet specific data and quality targets for case handling Remain current with case handling SOPs, guidance documents and database technology Organizes workload to ensure compliance with SDEA and other global regulatory reporting requirements for ICSR.
Demonstrates general understanding of appropriate labeling documents for Client products.
Ensures departmental workflow processes and timelines are followed Works with Submissions Team to properly identify global regulatory reporting requirements especially for Client sponsored clinical trials reports May assist manager in the preparation of training material and assist in training new employees May assist with other projects as necessary (i.
e, study unblinding).
Perform clinical trial reconciliation with minimal supervision from Manager or Sr Safety Specialist Identify cases requiring investigator letters and draft investigator letters with minimal supervision from Manager or Sr Safety Specialist May triage and assign the incoming reports.
Acts as a trainer and mentor for more junior staff members.
Participate in some clinical trial activities with supervision from Manager or Sr Safety Specialist (i.
e.
, protocol & CRF reviews, data management plan reviews, CRO agreements & flows) May participates in Study Management Teams (as applicable) May assists in the development of drug safety presentation for investigator meeting presentations.
The ability to assess data and understand the medical/safety implications.
Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred Ability to follow guidelines and procedural documents Self-motivated and capable of working independently Understands safety database structures and is familiar with data retrieval tools.
Case processing experience is preferred Knowledge of clinical trials activities preferred Medical Safety Coding (MSC) Entry level, participates in initial period of training under direct supervision of manager, and then works under minimal supervision.
Supports MSC Coding Group and assists in coding of adverse event and medication terms for clinical and post-marketing data using the MedDRA and WHO Drug coding dictionaries, and collaborates with Clinical Data Management (CDM) to assist in timely completion of coding jobs.
Provides functional group administrative support and assists in other projects as needed.
Assists in quality control of document archives and contributes to improvement of established processes.
Demonstrates proficiency in verbal and email communication, including Microsoft Excel, Word, and Power Point.
Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality.
Contributes toward completion of organizational projects and goals, and maintains meticulous attention to project deadlines.
Demonstrates extensive knowledge in a specialized function, and a wide and comprehensive knowledge of both general and specific aspects of the job and their practical application to complex problems and situations.
Recognizes and seeks interdepartmental assistance for missing data; interdepartmental contacts are frequent and involve planning and preparation of communications.
Job Types:
Contract, Temporary Salary:
$19.
00 - $26.
00 per hour
Benefits:
401(k) Dental insurance Health insurance Vision insurance Schedule:
8 hour shift Ability to commute/relocate:
Foster City, CA 94404:
Reliably commute or planning to relocate before starting work (Required)
Experience:
data entry of ICSRs:
1 year (Required) adverse event reports and regulatory submissions.
:
1 year (Preferred) Work Location:
One location Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
8 Quick Apply Temporary Contract 5 hours ago Full Job Description Duties:
Operations Sets work priorities and direction with input from Manager.
Responsible for the accurate and timely book-in and acknowledgement of adverse event information in compliance with applicable Client SOPs and guidelines.
Perform simple queries of the safety database, e.
g.
duplicate searches.
Maintain and manage dept Safety mailbox, distributing to relevant parties as applicable.
May perform initial data entry of ICSRs (review, extract, accurately enter AE data from ICSR reports).
May interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.
Meet specific data and quality targets for case handling Responsible for regulatory submissions of ICSR and aggregate reports.
Assist with tracking and reconciliation of incoming adverse event reports, Investigator letter distribution, and regulatory submissions.
Coordinate submission of product complaints to the Quality assurance department.
Participate in department projects, as required and will be cross-trained to handle other functions as deemed necessary Recognizes situations that require assistance from more senior staff members and seeks assistance from appropriate internal and external resources.
Assists Safety Specialists in sending and tracking follow-up letters.
Remain current with case handling SOPs, guidance documents and database technology Ensures compliance with SDEA and other global regulatory reporting requirements for ICSR May assist manager in the preparation of training material and assist in training new employees their functional area.
May assist manager with writing/reviewing guideines for their functional area of expertise.
May assist with other projects as necessary (i.
e, study unblinding, reconciliation with vendors, etc) Ensures departmental workflow processes and timelines are followed
Qualifications:
Excellent interpersonal communication skills, both written and oral Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).
Safety database and data entry experience preferred Basic understanding of medical and drug terminology preferred Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred Demonstrates initiative, teamwork and accountability Demonstrated success working both independently and in collaboration with others A quality driven individual with strong attention to detail and accuracy is required Strong organizational skills, and ability to adapt to change A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strick timelines is required.
Ability to follow guidelines and procedural documents Operations Sets work priorities and direction with input from Manager.
Review, extract and accurately enter AE data from ICSR reports from both investigational and post marketing products.
Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.
Review, enter, and verify follow-up information for cases and make accurate determination of significant information Performs review of ancillary documentation accompanying ICSR reports and identifies pertinent information for incorporations into the case narrative Correctly identify cases requiring targeted follow-up, determine relevant follow-up required and prepare follow-up queries.
Have solid working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate.
Will interact with other Drug Safety functional areas to process adverse events efficiently and reliably.
Will liaise with clinical department, affiliate, marketing or contract research organizations as needed on safety data issues (i.
e.
, obtaining clarification or follow-up information).
Identifies issues/concerns in a timely and appropriate manner Meet specific data and quality targets for case handling Remain current with case handling SOPs, guidance documents and database technology Organizes workload to ensure compliance with SDEA and other global regulatory reporting requirements for ICSR.
Demonstrates general understanding of appropriate labeling documents for Client products.
Ensures departmental workflow processes and timelines are followed Works with Submissions Team to properly identify global regulatory reporting requirements especially for Client sponsored clinical trials reports May assist manager in the preparation of training material and assist in training new employees May assist with other projects as necessary (i.
e, study unblinding).
Perform clinical trial reconciliation with minimal supervision from Manager or Sr Safety Specialist Identify cases requiring investigator letters and draft investigator letters with minimal supervision from Manager or Sr Safety Specialist May triage and assign the incoming reports.
Acts as a trainer and mentor for more junior staff members.
Participate in some clinical trial activities with supervision from Manager or Sr Safety Specialist (i.
e.
, protocol & CRF reviews, data management plan reviews, CRO agreements & flows) May participates in Study Management Teams (as applicable) May assists in the development of drug safety presentation for investigator meeting presentations.
The ability to assess data and understand the medical/safety implications.
Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred Ability to follow guidelines and procedural documents Self-motivated and capable of working independently Understands safety database structures and is familiar with data retrieval tools.
Case processing experience is preferred Knowledge of clinical trials activities preferred Medical Safety Coding (MSC) Entry level, participates in initial period of training under direct supervision of manager, and then works under minimal supervision.
Supports MSC Coding Group and assists in coding of adverse event and medication terms for clinical and post-marketing data using the MedDRA and WHO Drug coding dictionaries, and collaborates with Clinical Data Management (CDM) to assist in timely completion of coding jobs.
Provides functional group administrative support and assists in other projects as needed.
Assists in quality control of document archives and contributes to improvement of established processes.
Demonstrates proficiency in verbal and email communication, including Microsoft Excel, Word, and Power Point.
Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality.
Contributes toward completion of organizational projects and goals, and maintains meticulous attention to project deadlines.
Demonstrates extensive knowledge in a specialized function, and a wide and comprehensive knowledge of both general and specific aspects of the job and their practical application to complex problems and situations.
Recognizes and seeks interdepartmental assistance for missing data; interdepartmental contacts are frequent and involve planning and preparation of communications.
Job Types:
Contract, Temporary Salary:
$19.
00 - $26.
00 per hour
Benefits:
401(k) Dental insurance Health insurance Vision insurance Schedule:
8 hour shift Ability to commute/relocate:
Foster City, CA 94404:
Reliably commute or planning to relocate before starting work (Required)
Experience:
data entry of ICSRs:
1 year (Required) adverse event reports and regulatory submissions.
:
1 year (Preferred) Work Location:
One location Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
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