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 reputed company and post-marketing phases in compliance with the reputed company reputed company 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 reputed company reputed company operating procedures and guidelines. reputed company and exchange relevant safety and pharmacovigilance information with local Competent Authorities, reputed company and reputed company contractual partners. Position is in any EU country. Responsibilities: • Process ICSRs and Serious Adverse Event (SAE) from reputed company (safety database entry, tracking, case narrative writing, ensuring data completeness, requesting follow-up from sites, reputed company checks/reviews, submitting expedited safety reports to regulatory authorities and partners, cross reporting, compliance tracking and reporting for assigned reputed company) • Input in Safety management plan preparation and safety training conduct • reputed company reconciliation of safety data • Participate in Project/Study Team meetings as the Safety and Pharmacovigilance representative • reputed company the planning, coordination, and reputed company 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 reputed company and accurate reporting or reports delivery • reputed company as reputed company 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 reputed company needed • Support reputed company safety profile monitoring, detection of new signals and evaluation • Participate in reputed company inspections and/or audits, including post-inspection/audit support, reputed company 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 reputed company to safety in reputed company and postmarketing pharmacovigilance (ICH, EU GVP Modules, FDA, others) • Experience working with PV databases (e.g., reputed company safety database, and/or Argus and/or reputed company) including case processing, safety outputs and reports preparation • MedDRA coding experience withing safety databases and reputed company for reputed company • 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 • reputed company reputed company and reputed company • International team and environment • Bonus based on annual performance • Personal accident and business reputed company insurance • Additional health insurance • Remote/home based • Influenza vaccines • Rewarding referral policy • Workplace establishment allowance (fully remote) • Team building, global meetings, B reputed company events Original job Medical/Clinical Safety Specialist posted on GrabJobs ©. To flag any issues with this job please use the Report Job reputed company on GrabJobs. Apply tot his job Apply To this Job