Scientist, Biopharma Safety Management / Remote - (JP8892)
3key Consulting
2021-10-23T23:37:22Z
Thousand Oaks
California
United States
Scientific Research
(No Timezone Provided)
Job Title: Scientist, Biopharma Safety Management / Remote - (JP8892)
Location: Thousand Oaks, Ca. (Remote work)
Employment Type: Contract
Business Unit: GPS Safety Management
Duration: 4 months with possible extension
Posting Date: 7/21/21
3 Key Consulting is hiring a Scientist for a consulting engagement with our client, a leading global biopharmaceutical company.
Must have a degree and 2+ years of relevant experience. Signal detection and report preparation is a must have.
Job Description:
The Global Pharmacoviglance Scientist (GPvS) will join a team of PV Scientists working in collaboration with the Global Safety Officers (GSOs) to provide the safety strategy and major safety deliverables for company product. The Immuno-oncology teams has an exciting portfolio of products ranging form Early Development through Marketed products.
The GPvS provides medical and safety input into the clinical scope, review criteria, analysis and interpretation of safety data. To develop and execute the safety surveillance strategy for product candidates/products in clinical development programs/approved products. To support the GSO [Global safety Officer] in preparation of safety deliverables.
Job Summary:
This role provides medical content and technical support to the Global Safety Team (GST) in the evaluation of safety data and production of GST deliverables under the supervision of the GSO.
Key Activities:
Support Global Safety Officer in the clinical interpretation of safety signals and evaluations of aggregate safety data including analytical strategy and search methodology. Responsible for producing presentations for team meetings and other scientific presentations under the guidance of the GSO. Contribute content support to the development of strategy and creation of product risk management plans, safety updates, safety assessment reports, and other GST deliverables. Safety content and expertise in support of IND filings, Investigator Meetings, Data Monitoring Committees and Data Review Teams, responses to regulatory authorities, safety sections of Clinical Study Reports, Clinical Summary of Safety, and other clinical trial documents
Competencies: Understand clinical trials and drug development. Clinical knowledge of therapeutic area patient populations and drug class. Understand safety data capture in CT and PM settings. Understanding of Medical Coding principles MedDRA. Knowledge of global safety requirements for worldwide pharmacovigilance. Critical Scientific thinking and problem solving.
Attention to Detail. Teamwork and Interpersonal Skills. Microsoft Suite (Outlook, Word, Excel, PowerPoint). Organizational and Time Management Skills. Oral Presentation Skills. Written communications including medical writing. Basic Qualifications: MD, 2+ years experience. Drug safety/drug development experience. Adverse Event Management.
Why is the Position Open? Planned Project
Top Must-Have Skill Sets: Signal detection experience Periodic report preparation Document review such as clinical trial protocols, ICFs, Investigator brochures Day to Day Responsibilities: Work with assigned product teams (Global Safety Officer, and other PV Scientists). Review of signal detection outputs, signal assessments as needed.
Working with cross-functional teams to provide input into study documents ie protocol, study specific informed consent forms, responses to RTQs from Health Authorities. Assist in contributions to periodic reports. Clinical background preferred, ie nurse, pharmacist.
Employee Value Proposition: The chance to gain valuable working experience at an industry leader and possibly extend beyond the initial contract duration.
Red Flags: Less than 1 yr experience in PV. Experience in ICSR (case processing) only.
Interview process: Phone/Video Interviews
We invite qualified candidates to send your resume to
[email protected]. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Scientist, Biopharma Safety Management / Remote - (JP8892)
Job Title: Scientist, Biopharma Safety Management / Remote - (JP8892)
Location: Thousand Oaks, Ca. (Remote work)
Employment Type: Contract
Business Unit: GPS Safety Management
Duration: 4 months with possible extension
Posting Date: 7/21/21
3 Key Consulting is hiring a Scientist for a consulting engagement with our client, a leading global biopharmaceutical company.
Must have a degree and 2+ years of relevant experience. Signal detection and report preparation is a must have.
Job Description:
The Global Pharmacoviglance Scientist (GPvS) will join a team of PV Scientists working in collaboration with the Global Safety Officers (GSOs) to provide the safety strategy and major safety deliverables for company product. The Immuno-oncology teams has an exciting portfolio of products ranging form Early Development through Marketed products.
The GPvS provides medical and safety input into the clinical scope, review criteria, analysis and interpretation of safety data. To develop and execute the safety surveillance strategy for product candidates/products in clinical development programs/approved products. To support the GSO [Global safety Officer] in preparation of safety deliverables.
Job Summary:
This role provides medical content and technical support to the Global Safety Team (GST) in the evaluation of safety data and production of GST deliverables under the supervision of the GSO.
Key Activities:
Support Global Safety Officer in the clinical interpretation of safety signals and evaluations of aggregate safety data including analytical strategy and search methodology. Responsible for producing presentations for team meetings and other scientific presentations under the guidance of the GSO. Contribute content support to the development of strategy and creation of product risk management plans, safety updates, safety assessment reports, and other GST deliverables. Safety content and expertise in support of IND filings, Investigator Meetings, Data Monitoring Committees and Data Review Teams, responses to regulatory authorities, safety sections of Clinical Study Reports, Clinical Summary of Safety, and other clinical trial documents
Competencies: Understand clinical trials and drug development. Clinical knowledge of therapeutic area patient populations and drug class. Understand safety data capture in CT and PM settings. Understanding of Medical Coding principles MedDRA. Knowledge of global safety requirements for worldwide pharmacovigilance. Critical Scientific thinking and problem solving.
Attention to Detail. Teamwork and Interpersonal Skills. Microsoft Suite (Outlook, Word, Excel, PowerPoint). Organizational and Time Management Skills. Oral Presentation Skills. Written communications including medical writing. Basic Qualifications: MD, 2+ years experience. Drug safety/drug development experience. Adverse Event Management.
Why is the Position Open? Planned Project
Top Must-Have Skill Sets: Signal detection experience Periodic report preparation Document review such as clinical trial protocols, ICFs, Investigator brochures Day to Day Responsibilities: Work with assigned product teams (Global Safety Officer, and other PV Scientists). Review of signal detection outputs, signal assessments as needed.
Working with cross-functional teams to provide input into study documents ie protocol, study specific informed consent forms, responses to RTQs from Health Authorities. Assist in contributions to periodic reports. Clinical background preferred, ie nurse, pharmacist.
Employee Value Proposition: The chance to gain valuable working experience at an industry leader and possibly extend beyond the initial contract duration.
Red Flags: Less than 1 yr experience in PV. Experience in ICSR (case processing) only.
Interview process: Phone/Video Interviews
We invite qualified candidates to send your resume to
[email protected]. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.