Medical/Clinical Safety Specialist
Join our global Pharmacovigilance team as a Medical/Clinical Safety Specialist.
Medical/Clinical Safety Specialist is responsible for monitoring, evaluating, and ensuring the safety of medicinal products during clinical trials and post-marketing phases in compliance with the Biomapas Quality Management System and safety requirements.
Participate in the collection, safety review, processing and reporting of safety information in compliance with applicable global and local regulations and Biomapas standard operating procedures and guidelines. Interact and exchange relevant safety and pharmacovigilance information with local Competent Authorities, Biomapas and Biomapas contractual partners.
Position is in any EU country.
Responsibilities:
• Process ICSRs and Serious Adverse Event (SAE) from Clinical trials (safety database entry, tracking, case narrative writing, ensuring data completeness, requesting follow-up from sites, quality checks/reviews, submitting expedited safety reports to regulatory authorities and partners, cross reporting, compliance tracking and reporting for assigned projects)
• Input in Safety management plan preparation and safety training conduct
• Perform reconciliation of safety data
• Participate in Project/Study Team meetings as the Safety and Pharmacovigilance representative
• Oversee the planning, coordination, and quality review of aggregate safety reports, support the preparation and submission of regulatory safety documents (e.g., DSURs, 6MLL)
• Supervision of local handling, including preparation and submission, of Periodic Safety Update Reports, Risk Management Plans and risk minimization activities
• Collaborate with medical, safety physicians, and data management, PV technology group, other functions to ensure timely and accurate reporting or reports delivery
• Act as Biomapas and/or contractual partners 24/7 local contact person or back up for clinical safety questions
• Ensure the survey and monitoring of national/regional pharmacovigilance regulations
• Support weekly monitoring of local or global literature reviews, case intake, and safety database data entry when needed
• Support continuous safety profile monitoring, detection of new signals and evaluation
• Participate in related inspections and/or audits, including post-inspection/audit support, when required
• University degree in the Life Science field
• At least 5+ year’s experience in Pharmacovigilance, clinical safety and clinical development and expert knowledge of pharmacovigilance legislation
• Knowledge of international regulations related to safety in clinical trials and postmarketing pharmacovigilance (ICH, EU GVP Modules, FDA, others)
• Experience working with PV databases (e.g., Veeva safety database, and/or Argus and/or ArisGlobal) including case processing, safety outputs and reports preparation
• MedDRA coding experience withing safety databases and manual for AEs
• Strong computer literacy
• Ability to interpret and apply global drug safety regulations
• Fluent English language
• Eager to adopt automations and new technologies in daily tasks
• Attention to detail, time-management and problem-solving skills
• CRO experience is a plus
• Project management experience is a plus
• Professional growth and career opportunities
• International team and environment
• Bonus based on annual performance
• Personal accident and business trip insurance
• Additional health insurance
• Remote/home based
• Influenza vaccines
• Rewarding referral policy
• Workplace establishment allowance (fully remote)
• Team building, global meetings, B active events
Original job Medical/Clinical Safety Specialist posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.
Apply tot his job
Apply To this Job
Medical/Clinical Safety Specialist is responsible for monitoring, evaluating, and ensuring the safety of medicinal products during clinical trials and post-marketing phases in compliance with the Biomapas Quality Management System and safety requirements.
Participate in the collection, safety review, processing and reporting of safety information in compliance with applicable global and local regulations and Biomapas standard operating procedures and guidelines. Interact and exchange relevant safety and pharmacovigilance information with local Competent Authorities, Biomapas and Biomapas contractual partners.
Position is in any EU country.
Responsibilities:
• Process ICSRs and Serious Adverse Event (SAE) from Clinical trials (safety database entry, tracking, case narrative writing, ensuring data completeness, requesting follow-up from sites, quality checks/reviews, submitting expedited safety reports to regulatory authorities and partners, cross reporting, compliance tracking and reporting for assigned projects)
• Input in Safety management plan preparation and safety training conduct
• Perform reconciliation of safety data
• Participate in Project/Study Team meetings as the Safety and Pharmacovigilance representative
• Oversee the planning, coordination, and quality review of aggregate safety reports, support the preparation and submission of regulatory safety documents (e.g., DSURs, 6MLL)
• Supervision of local handling, including preparation and submission, of Periodic Safety Update Reports, Risk Management Plans and risk minimization activities
• Collaborate with medical, safety physicians, and data management, PV technology group, other functions to ensure timely and accurate reporting or reports delivery
• Act as Biomapas and/or contractual partners 24/7 local contact person or back up for clinical safety questions
• Ensure the survey and monitoring of national/regional pharmacovigilance regulations
• Support weekly monitoring of local or global literature reviews, case intake, and safety database data entry when needed
• Support continuous safety profile monitoring, detection of new signals and evaluation
• Participate in related inspections and/or audits, including post-inspection/audit support, when required
• University degree in the Life Science field
• At least 5+ year’s experience in Pharmacovigilance, clinical safety and clinical development and expert knowledge of pharmacovigilance legislation
• Knowledge of international regulations related to safety in clinical trials and postmarketing pharmacovigilance (ICH, EU GVP Modules, FDA, others)
• Experience working with PV databases (e.g., Veeva safety database, and/or Argus and/or ArisGlobal) including case processing, safety outputs and reports preparation
• MedDRA coding experience withing safety databases and manual for AEs
• Strong computer literacy
• Ability to interpret and apply global drug safety regulations
• Fluent English language
• Eager to adopt automations and new technologies in daily tasks
• Attention to detail, time-management and problem-solving skills
• CRO experience is a plus
• Project management experience is a plus
• Professional growth and career opportunities
• International team and environment
• Bonus based on annual performance
• Personal accident and business trip insurance
• Additional health insurance
• Remote/home based
• Influenza vaccines
• Rewarding referral policy
• Workplace establishment allowance (fully remote)
• Team building, global meetings, B active events
Original job Medical/Clinical Safety Specialist posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.
Apply tot his job
Apply To this Job