About the role
Join our global Pharmacovigilance team as a Medical/Clinical Safety Specialist.
Medical/Clinical Safety Specialist is responsible for assuring compliance with the Quality Management System. Participating 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. All CV's must be submitted in English language.
Responsibilities:
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
Requirements
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 (ICH, EU GVP Modules, FDA)
Experience working with PV databases (e.g., Veeva Vault Safety, Argus, ArisG, etc) and MedDRA coding
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
Benefits
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
Rewarding referral policy
Workplace establishment allowance (fully remote)
Team building, global meetings, B active events
Originally posted on Himalayas