Medical Affairs/Safety - Manager, PV Scientist - Contract
TalentBurst, Inc.
- Cambridge, MA
- 1 day ago
- $113.55 Per Hour
Highlights
Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas. Contributes to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.
Numbers & Facts
| Location | Cambridge, MA |
| Industry | Staffing/Employment Agencies |
| Salary | $113.55 Per Hour |
| Company Size | 5,000 to 9,999 employees |
| Year Founded | 2002 |
| Website | http://www.talentburst.com/ |
Description
PV Scientist, Contractor, Safety Risk Management
6 Months
Remote
Summary of Key Responsibilities
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Qualifications
Education: Degree in a medical or healthcare related discipline (PharmD, RN, MD) is required
Experience: A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. Previous experience in managing drug safety personnel a plus. Specific experience in RNA therapeutic area at a global level is an advantage.
Strong skills and experience in:
Ability to work in a matrix environment in accordance with the company leadership commitments and values.
Excellent planning, organization, written and oral communication skills
Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
Understanding Signaling tools (eg. Empirica)
Experience in clinical patient care is a plus
Regulatory Inspection readiness experience is a plus
Supervision:Â Individual is expected to work independently with support from management and colleagues in SRM.
#TB_PH
#ZR
6 Months
Remote
Summary of Key Responsibilities
- Works closely with the safety lead physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
- Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
- Assists in evaluation and development of Safety Management Plans
- Assists in data analysis compilation and presentation at cross-functional meetings.
- Assists in the evaluation of potential safety issues.
- Contributes to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.Â
- Contributes to the development and management of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety. Â
- Assists in RMP and DRMP development and updates.
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Qualifications
Education: Degree in a medical or healthcare related discipline (PharmD, RN, MD) is required
Experience: A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. Previous experience in managing drug safety personnel a plus. Specific experience in RNA therapeutic area at a global level is an advantage.
Strong skills and experience in:
Ability to work in a matrix environment in accordance with the company leadership commitments and values.
Excellent planning, organization, written and oral communication skills
Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
Understanding Signaling tools (eg. Empirica)
Experience in clinical patient care is a plus
Regulatory Inspection readiness experience is a plus
Supervision:Â Individual is expected to work independently with support from management and colleagues in SRM.
#TB_PH
#ZR
About Company
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!
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