• Monitor mailbox/dump/allocation sheet on business days, for arrival of any new ICSR or follow-up information.
• Follow processes per client SOPs.
• If new case, perform minimum data entry (triage fields)
• If duplicate, attach new source documents to existing cases in an active workflow
• If duplicate and previous versions are in distribution, evaluate for void and consolidation as appropriate.
• If invalid, send details to the sponsor for agreement/additional information.
• Code all events as per MedDRA, identifying seriousness as per the ATL list, and updating relatedness.
• Enter seriousness, labeling, and causality assessment as per conventions
• Prioritize for workflow management
• Send queries for any missed or illegible information
• Acknowledgement to client and update of related trackers
• Evaluate all triage fields for accuracy and make appropriate corrections.
• Provide feedback on triage-related errors.
• Full data entry, including labeling and narrative writing as appropriate
• Liaise with another client point of contact to clarify appropriate information required for case processing

Skills: Case Management, Process Adherence, Data Entry, Duplicate Case Evaluation, Seriousness & Causality Assessment, Workflow Prioritization, Query Management, Client Liaison

• Execute and support all local pharmacovigilance and Risk Management (RM) related activities as directed by the Head of Drug Safety and Risk Management
• Ensure compliance with local and international regulations as well as internal standards.
• Contribute effectively as part of the Worldwide Patient Safety network.
• Represent the Drug Safety and Risk Management Department within the affiliate as a point of reference internally for Drug Safety and Risk Management Queries
• Work closely with the Global Drug Safety and Risk Management team to fulfill any requests including follow-up queries.
• Timely escalation of potential compliance issues and deviations
• Support the development of non-compliance observations and associated CAPAs.
• Maintain the local archive of safety reports.
• Contribute to the development, update, and maintenance of SOPs/WPs and associated documents.
• Complete adverse event reconciliations for vendors involved in, but not limited to, patient support programs, medical information, and investigator-initiated trials on a frequency determined by the agreement.

Skills: Pharmacovigilance, Risk Management, Regulatory Compliance, Global Collaboration, Drug Safety Query Resolution, Compliance Escalation, CAPA Development, Adverse Event Reconciliation

• Assist the QPPV in maintaining the Pharmacovigilance system and related quality systems
• Prepare and review Annual Safety Reviews and Periodic Safety Update Reports
• Download and process ICSRs for company products from the EMA’s Medical Literature Monitoring Service (MLM)
• Prepare and maintain Safety Data Exchange Agreements
• Triage, process, and follow up all ICSRs for all company products following applicable regulations, SOPs, and safety data exchange agreements
• Report adverse event reports to the Health Authorities in line with local requirements
• Process Individual Case Safety Reports and ensure timely completion of all case processing activities in line with local regulations and company requirements.
• Work in collaboration with the Global Patient Safety team on case management activities.
• Conduct PV activities in line with regulations and Company SOPs and comply with the ABPI Code of Practice
• Maintain awareness of PV regulatory requirements and developments.

Skills: Pharmacovigilance System Management, Safety Review Preparation, ICSR Processing, Safety Data Exchange, Adverse Event Reporting, Case Management, Regulatory Compliance, PV Regulatory Awareness

• Prepare and produce global periodic safety regulatory reports and reports required for submission to Health authorities worldwide
• Prepare, produce, and manage global Risk Management Plans
• Perform Global Signal Management for products across the globe
• Identify new safety information published or communicated by Health Authorities worldwide in line with the Safety Trigger Monitoring process
• Support in the development of the Global Company Core Data Sheet (CCDS) and production of Global Reference Safety Information
• Support and response to questions raised by Health Authorities worldwide
• Conduct or lead with guidance, the discussion and management of safety issues and presentation of findings to governance bodies
• Support and guide regional and local PV teams within the company
• Responsible for the collection, data entry, routing, follow-up, and timely reporting/submission of safety information, in compliance with SOPs, US regulations, and international regulations.
• Conduct periodic, detailed audits to ensure the integrity of AE processing, thoroughness of documentation, accuracy of results, and timeliness of reports.
• Responsible for self-initiated quality review within each distinct process step.

Skills: Global Safety Reporting, Risk Management Plans, Signal Management, Safety Information Monitoring, Global Data Sheet Development, Health Authority Communication, Safety Issue Management, Quality Auditing

• Performs thorough investigation of Clinical Study serious adverse events (SAEs) through to completion
• Conducts clinical evaluation and obtains medically relevant guidance/approval from upper management
• Works closely with Clinical Research Managers/Associates, CROs, and study sites for adverse event investigations and reconciliations, CRF/SAE form discrepancies, and safety query reconciliations to follow and resolve issues to resolution.
• Revise and approve SAE narratives
• Provides all necessary study start-up training, forms, and risk documents to assigned study teams.
• Attends study team meetings, under the supervision of PV management provides PV expertise/guidance, and communicates issues to PV upper management as applicable
• Participate in study-specific signal detection activities and preparation of Ad Hoc Reports.
• Review, approve, and/or prepare an analysis of similar events (AoSE)
• Participates in the development of PV infrastructure, and participates in the identification and implementation of efficiencies.
• Oversees PV CRO quality, and compiles metrics for Clinical Department periodic review
• Participates in process improvement activities, identifies needs, and drafts SOPs
• Applies clinical knowledge and expertise, information gathering, and analytical/interpretation skills to evaluate adverse events
• Reviews assigned internal and external clinical databases and ensures the resolution of inconsistencies with safety databases, escalates unusual problems or identified safety trends to senior PV management
• Manages the maintenance of PV-related documents within the safety Trial Master File
• Assists in final data cleaning activities before database lock and each analysis timepoint (EDC review of outstanding safety queries, table/line listing review before data transfer)

Skills: Serious Adverse Event Investigation, Clinical Evaluation, Adverse Event Reconciliation, SAE Narrative Revision, Study Start-up Training, Signal Detection, Safety Data Analysis, Process Improvement

• Experience in Pharmacy and medical sciences with health professional qualification
• Experience working within a Pharmacovigilance Department
• Ability to produce high-quality, accurate work (oral, written, and presentation) to meet deadlines
• Well-developed scientific analytical skills to present complex data in an accurate and understandable manner
• Working knowledge of regulatory requirements about pharmacovigilance in the pre-and post-approval environments
• Well-developed time management, communication, presentation, and interpersonal skills
• Responsible, flexible, and accountable with a pro-active approach and able to work to deadlines
• Ability to plan and prioritize multitask/multi-project workload
• Experience in the use and management of Drug Safety Databases and MedDRA coding.
• Skilled in Microsoft Office applications (Word, PowerPoint, and Excel)
• Knowledge of GXP Scope (Good Pharmacovigilance Practice).

Qualifications: BS in Pharmacology with 4 years of Experience

• Prior Good Clinical Practice (GCP) training
• Prior Clinical Safety reporting experience
• A good working knowledge of the Argus safety database
• Computer literacy in MS Word, Excel, and PowerPoint, and database work
• Ability to diplomatically address sensitive issues confidentially and professionally
• Self-starter, able to work with a high degree of independence
• Ability to manage cases from multiple projects simultaneously while maintaining a high level of quality
• Working knowledge of ICH, European Commission, and FDA Guidances and Regulations about Adverse Event (AE) reporting
• Strong knowledge and understanding of medical terminology and clinical information
• Effective communicator (written and oral), concise, accurate, and business-appropriate
• Excellent attention to detail and effective organization
• Demonstrated critical thinking and problem-solving skills, with the ability to manage multiple tasks with deadlines
• Proven effective collaboration with multifunctional areas (Data Management, Clinical Operations, Regulatory Operations)
• Excellent interpersonal skills

Qualifications: BS in Biology with 5 years of Experience

• Previous pharmacovigilance experience
• Good organizational and time management skills
• Ability to multi-task and prioritize
• Good communication skills (both written and oral)
• Must have great attention to detail
• Good computer skills including experience with Microsoft Office
• Have strong identification with Celgene's values
• Awareness of regulatory requirements related to pharmacovigilance
• Awareness of the link between regulations, drug development, and drug safety.
• Awareness of the role of compliance in drug safety.
• Awareness of the use of databases and other software applications.

Qualifications: BS in Biochemistry with 1 year of Experience

• Good verbal, written communication, and presentation skills.
• Ability to interact and influence line and middle management, staff, and external contacts on a functional and tactical level.
• Functions as a team player, with a high degree of accuracy with attention to detail.
• Ability to present and share useful business information across departments and functions.
• Ability to anticipate and identify problems and take appropriate action to correct them.
• Knowledge of medical and drug terminology
• Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
• Knowledge of ICH Guidelines
• Knowledge of Medical Device Reporting
• Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products.
• Good knowledge and understanding of industry and RandD processes and objectives.
• Ability to work independently with minimal supervision
• Good keyboard skills, preferably with knowledge of MS Office and Windows

Qualifications: BS in Chemistry with 3 years of Experience

• Experience in life science, healthcare, or other appropriate scientific fields
• Experience working in a similar Pharmacovigilance/Drug Safety role.
• Experience in Clinical Development/Research (with adverse event experience)
• Basic understanding of medical/scientific terminology
• Excellent level of written and verbal English
• Good level of computer literacy with Microsoft applications
• Very high level of accuracy and attention to detail
• Excellent organization skills and ability to prioritize
• Data entry experience with a safety database experience
• Demonstrated success working both independently and in collaboration with others
• Excellent decision-making and problem-solving skills

Qualifications: BS in Public Health with 2 years of Experience