Lead safety science activities for cell therapy assets within the Global Patient Safety Unit, integrating data, managing risk, and supporting regulatory submissions.
Compensation
The annual base pay for this position ranges from $132K to $199K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
Conduct and coordinate safety surveillance, signal detection, validation, evaluation and management for assigned cell therapy assets
Develop MedDRA search strategies
Translate emerging safety data into clear analyses and recommendations
Lead components of pharmacovigilance and risk‑management planning
Author and project‑manage aggregate reports and safety deliverables
Requirements
Bachelor’s degree in life sciences, pharmacy, nursing or a related discipline
Advanced degree in immunology, autoimmune disease, pharmacology or a related discipline
Lead safety science activities for cell therapy assets within the Global Patient Safety Unit, integrating data, managing risks, and supporting regulatory submissions.
Compensation
The annual base pay for this position ranges from $132K to $199K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
Conduct and coordinate safety surveillance, signal detection, validation, evaluation and management for assigned cell therapy assets
Develop MedDRA search strategies
Translate safety data into analyses and recommendations
Lead pharmacovigilance and risk‑management planning
Author and project‑manage safety reports and deliverables
Requirements
Bachelor’s degree in life sciences, pharmacy, nursing or a related discipline
Advanced degree in immunology, autoimmune disease, pharmacology or a related discipline
Manages the safety profile of new drugs in clinical trials, oversees case-processing activities through all phases of development, and performs regulatory reporting and medical monitoring tasks.
Responsibilities
Coordinates contracted safety responsibilities for one or more programs, including staffing, training, procedural compliance and technology oversight
Manages the safety team on respective programs
Works with senior management and develops consistent internal processes and ensures compliance with established processes
Proactively liaises with project leads and clients to ensure optimal performance and utilisation of the safety project team and delivery of a high quality service to our clients
Directly fulfils safety scientist activities on assigned projects
Requirements
Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Lead and manage a team of Pharmacovigilance Scientists to oversee safety surveillance, signal detection, risk management, and regulatory compliance for drug safety across the product lifecycle.
Compensation
$185,000.00-252,500.00 Annual
Responsibilities
Allocate resources across products and development programs to ensure timely execution of safety deliverables
Foster a culture of scientific excellence, collaboration, continuous improvement, and regulatory compliance
Provide scientific oversight of routine and ad hoc signal detection activities for investigational and marketed products
Lead the preparation, maintenance, and lifecycle management of core Risk Management Plans (RMPs) and associated safety documents
Ensure consistency between RMPs, Core Safety Information, Investigator's Brochures, and product labeling
Requirements
Master's degree or PhD in Pharmacy, Pharmacology, Life Sciences, Nursing, Public Health, or a related scientific discipline
Specialist in GPS Operations DK responsible for processing adverse event reports, medical coding, and supporting clinical trial safety activities within Lundbeck's Global Patient Safety Operations.
Process and assess adverse event case reports in accordance with internal procedures and global PV regulations, ensuring accuracy, completeness and timely reporting.
Perform medical coding using MedDRA and contribute to high-quality safety data management.
Support clinical trial safety activities, including trial-related reporting and narrative writing, and participate in cross-functional safety teams.
Develop and maintain process documentation, including SOPs, work instructions and steering documents, and support inspection and audit activities when needed.
Requirements
Bachelor's in health or natural sciences, such as pharmacy, public health, biology or a related field
Perform medical review and assessment of Individual Case Safety Reports (ICSRs), conduct signal detection and evaluation, analyze aggregate safety data, support preparation of safety reports, and collaborate with cross-functional teams to ensure patient safety.
Compensation
Salary Range: Based on your Previous CTC
Responsibilities
Perform medical review and assessment of Individual Case Safety Reports (ICSRs)
Conduct signal detection and signal evaluation using safety databases and statistical tools
Analyze aggregate safety data to identify emerging safety trends
Support preparation and review of Periodic Safety Update Reports (PSURs), PBRERs, DSURs, and Risk Management Plans (RMPs)
Participate in signal management activities including validation, prioritization, documentation, and escalation
Requirements
MBBS
Nice to have: postgraduate qualification in Pharmacology, Clinical Research, or Drug Safety
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