Sr. PV 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:- 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)
- Support of continuous safety profile monitoring, detection of new signals and evaluation
- 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
- 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
- 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
- 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
Skills Required
- University degree in Life Sciences
- At least 5 years' experience in Pharmacovigilance, clinical safety, and clinical development
- Expert knowledge of pharmacovigilance legislation and ability to interpret/apply global drug safety regulations
- Knowledge of international regulations (ICH, EU GVP Modules, FDA)
- Experience with PV databases (e.g., Veeva Vault Safety, Argus, ArisG) and MedDRA coding
- Strong computer literacy and openness to automation/new technologies
- Fluent English
- Attention to detail, time-management, and problem-solving skills
- CRO experience
- Project management experience
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What We Do
Biomapas is a functional and full outsourcing solution provider to the global life science industry. As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success. We keep our promises. Always. Social media privacy policy: bit.ly/privacy-biomapas
