Pharmacovigilance Specialist (Medical/Clinical Safety)

Join our global Pharmacovigilance team as a Pharmacovigilance Specialist (Medical/Clinical Safety).

• →Responsible for processing of ICSRs, Serious Adverse Event (SAE) from Clinical trials (safety database entry, tracking, narrative writing, requesting follow-up from site, quality checks/review and reporting to client (s) or agencies for assigned projects)

• →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, IT, 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 pharmacovigilance at local level
• →Ensure the survey and monitoring of national / regional pharmacovigilance regulations
• →Collection and processing of any medical enquiry/inquiry/answer received via phone/e-mail/fax or by other means from any source
• →Support of weekly monitoring of local or global literature review
• →Support of continuous safety profile monitoring, detection of new signals and evaluation
• →Participate in related inspection and/or audits, including post inspection/audit support, when required

• University degree in the Life Science field
• At least 4+-years’ experience in Pharmacovigilance, clinical safety and clinical development and expert knowledge of pharmacovigilance legislation
• Knowledge of international regulations (ICH, EU GVP Modules, FDA)
• Experience working with PV databases (e.g., Argus, ArisG) and MedDRA coding
• Ability to interpret and apply global drug safety regulations
• Fluent English and local country language
• Eager to adopt automations and new technologies in daily tasks
• Attention to detail, time-management and problem-solving skills
• Project management experience is beneficial