Sr. Pharma Spec. (6M) at Lexington

Job Description

Job Description:This position works in a team oriented environment and will have the primary responsibility for:Data entry of incoming reports from clinical trials and post marketing sources in accordance with applicable regulations, company SOP;s and applicable licensing agreements with high level of accuracy, accountability, and minimal supervisionTriage incoming reports for initial assessment of seriousness, expectedness, causality, and reportability for reports from clinical trials and post marking sources in accordance with local work instructions, US FDA regulations, and international guidelines and regulations with high level of accuracy, accountability, and minimal supervisionIn situations where case processing activities are outsourced, the Senior Specialist is expected to play a key role in vendor management and oversightPerform active follow-up via verbal or written contact with healthcare professionals and consumersCoordinate with other departments, external organizations, and corporate partners to develop and implement industry standard procedures and processes for Pharmacovigilance activitiesWork independently to accomplish objectives within deadlinesContributing to regulatory submissions (IND and NDA), reviewing case report form data for safety issues, reconciling clinical trial data, and participating in clinical protocol developmentAbility to work with external teams by assisting with implementing overall planning, development, and data entry specifications for clinical trials or post marketing projectsAssist with monitoring compliance and additional quality metricsAssisting with writing and maintaining standard operating procedures and guidelines for case processing operationsGenerating internal and external report outputsCoding verbatim medical terms and medicationsActing as mentor for junior staff Providing internal and external safety trainingEstablishing industry standard procedures and processes for pharmacovigilance activitiesAssisting in responding to queries from health authorities or outside sourcesAny other assignments such as oversee database management, training, compliance, and/or case management under direction of managementAny other tasks as assignedMinimum Basic QualificationsA clinical degree (Pharm. D., RN) is required and/or BS in a life science degreeCompetence with US Code of Federal Regulations, EMA, and ICH safety reporting requirements/guidelines for adverse eventsCompetence with technology applications including commercial safety databasesExperience RequiredThree to five years Pharmacovigilance experience within the biopharmaceutical industryTwo years experience in clinical medical environment or similar experience providing strong knowledge of general medicine and drug therapyData entry experienceQuality Review experienceMedDRA coding experienceCompetencies DesiredMust be detail-oriented and have strong organizational and communication skillsStrong writing skillsAbility to work effectively as an individual contributorAbility to act as project team member and/or lead; collaborative spiritWork independently to accomplish individual and department objectives within deadlinesDemonstrate a capacity for accountability in his/her projectsEmployee will constantly demonstrate his/her positive attitude, reliability, and will strive for adherence to best practices.Employee will support establishment and implementation of goals and policies.Ability to independently identify problems and effectively offer solutionsExcellent interpersonal, communication, and personal organization skills; ability to prioritize workload and work effectively, sometimes within resource constraintsAbility to act as mentor and/or trainerORL

Job Requirements

 
Country: USA, State: Massachusetts, City: Lexington, Company: InVentiv Health.