Job Description
Title: Medical Reviewer, Associate Director, Safety and Risk Management (SRM)
Location: Remote - EST / CST
Duration: 6 months
Summary of Key Responsibilities
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Location: Remote - EST / CST
Duration: 6 months
Summary of Key Responsibilities
- Perform daily medical review and causality assessment of ICSRs in accurate, consistent, and timely manner to contribute to continuous signal detection and management process
- Collaborate with other pharmacovigilance colleagues to align on a harmonized approach to identifying, evaluating and communicating safety issues
- Identify topics for escalation and collaborate with safety product leads to investigate potential safety signals
- Collaborate with SRM Quality and Case Management teams to identify case review issues and inconsistency and work on addressing these issues under the leadership of Head of Medical Review
- Participate in process improvements for the Medical Review team
- Maintain close communication with the case processing and medical case review vendors
- MD degree with a minimum of 1 year of medical practice is required
- Must have a minimum of 2 years of pharmaceutical industry experience as a medical reviewer
- Sound clinical acumen and a wide range of therapeutic area knowledge.
- Ability to synthesize and analyze safety data from various sources. Proficiency in problem-solving within a highly complex environment
- Excellent written and oral communications skills
- Expertise in international regulations governing drug safety. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments highly preferred
- Ability to work in fast-paced environment with rapidly approaching timelines is important
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Numbers & Facts
| Location | Cambridge, MA (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $164.52–$175.86 Per Hour |
| Company Size | 5,000 to 9,999 employees |
| Year Founded | 2002 |
| Website | http://www.talentburst.com/ |
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!
Skills
- Biotech and Pharmaceuticalunmatched
- Case Managementunmatched
- Clinical Trialunmatched
- Data Analysisunmatched
- FDA (Food and Drug Administration)unmatched
- ICH Regulationsunmatched
- Identify Issuesunmatched
- Leadershipunmatched
- Pharmacovigilanceunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Process Improvementunmatched
- Product Safetyunmatched
- Quality Managementunmatched
- Regulationsunmatched
- Risk Managementunmatched
- Safety Processunmatched
- Supplier Relationship Management (SRM)unmatched
- Time Managementunmatched
- Writing Skillsunmatched
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