Parexel
Published
May 6, 2021
Location
USA
Category
Job Type
Work Setting
Remote / Home-based

Description

Excellent opportunity to join Parexel's Medical & Scientific Services Team as a Senior / Drug Safety Physician!

In this role you will:

*Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
*Signal detection/analysis/evaluation and ongoing safety surveillance activities
*Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety
*Provide medical advice/input for narratives written for Clinical Study Reports (CSRs)
*Provide medical, safety input and review of all required safety reports, such as- but not limited to - Periodic Safety *Update Reports (PSURs)/ Periodic Benefit Risk Assessment Reports (PBRERs)/ Periodic Adverse Drug Experience Reports (PADERS), Risk Management Plans (RMPs), Benefit Risk Assessment, Safety Evaluation Reports (SERs), Clinical Overview (COs), clinical Expert Statement, Investigator notification letters
*Function as pharmacovigilance representative/safety scientist

Key Accountabilities:

General:
*Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations
*Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
*Maintaining excellent knowledge of the safety profile of assigned products
*Communicating and discussing issues related to review process with Project Manager
*Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines
*Attend and present client/cross functional meetings along with other stakeholders

Case Report and Medical Review:
*Performing medical review of cases according to client Standard Operating
*Procedures (SOPs) and liaising with the client, as required
*Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
*Assessing seriousness and expectedness of reported events
*Providing medical advice to case processing team

Periodic Reports:
*Review and authoring of aggregate reports for medical context and consistency in accordance with client requirements and SOPs
*Providing medical advice to case processors for authoring of sections

Literature Review:
*Review of literature for product safety assessment and potential safety issues

CSR Narratives:
*Performing medical review of CSR narratives according to the client’s guidelines and SOPs

Safety Scientist:
*Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues
*Support the preparation and maintenance of Risk Management plans
*Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU renewal, Health Hazard Assessments and other Annual Safety/addendum reports) in accordance with regulatory requirements and standard operating procedures
*Support the preparation and maintenance of safety sections of the Company Core Data Sheet, local labels and Development Core Safety Information (DSCI)
*Coordinate safety activities between PDS and internal and external partners
*Conduct/support signal detection and evaluation according to SOPs and guidelines

Safety Scientist responsibilities continued:
*Conduct/support signal detection and evaluation according to SOPs and guidelines
*Prepare safety assessments, drug safety reports, as necessary, for potential signals or issues (product quality)
*Perform review and summarization of literature citations including epidemiology background research
*Provide safety content review of clinical protocols, study reports, Investigators Brochure and other related documents to ensure alignment with CDP
*Contribute to regulatory agency submissions (IND applications, NDAs, MAA’s, Variations, Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages
*Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable

Skills:
*Excellent interpersonal, verbal and written communication skills
*Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system
*Client focused approach to work
*A flexible attitude with respect to work assignments and new learnings
*Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
*Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential
*Willingness to work in a matrix environment and to value the importance of teamwork
*Strong knowledge of international drug regulation including GCP, GVP

Knowledge and Experience:
*Good knowledge of medical terminology.
*2+ years of previous Drug Safety Physician experience is required for a Drug Safety Physician role and 5+ years relevant experience required for a Senior Drug Safety Physician
*Previous Clinical, Safety, and PV Post-marketing experience are required

Education:
*MD, Board certified or Board eligible or equivalent medical training

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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