Parexel
Published
September 9, 2020
Location
Telecommute
Job Type
Work Setting
Remote / Home-based

Description

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.
*Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred.

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

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