Medical/Clinical Safety Specialist

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Biomapas

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Biomapas is a comprehensive outsourcing solution provider catering to the global life science sector. The company acts as a strategic partner for biopharmaceutical and medical device companies, offering extensive clinical research services worldwide. Biomapas covers the entire product lifecycle from regulatory compliance to pharmacovigilance and medical information. The company operates across various regions including Europe, CIS, EAEU, MENA, LATAM, and the US, ensuring high-quality, efficient, and cost-effective methodologies to deliver superior service and strategic advantages. With a focus on clinical trials, pharmacovigilance, and regulatory affairs, Biomapas is equipped to navigate complex regulatory environments and manage clinical trial data effectively, contributing to clients' commercial success.

📋 Description

• 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