Act as Local Contact Person for Pharmacovigilance for the designated country.
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.
Oversight of all project related quality activities
Drive project related quality improvement and providing quality advice
Client management including direct oversight for client quality related activities for project
PrimeVigilance, part of Ergomed Group, is a mid-sized pharmacovigilance service provider established in 2008. They offer services in medical information, pharmacovigilance, regulatory affairs, and quality assurance, with staff across Europe, North America, and Asia. They maintain long lasting relationships and becoming one of the global leaders in its fields.
Assist with investigator recruitment activities and site feasibility tasks.
Perform essential document collection, review, and maintenance activities.
Act as site contact for study and site management issues.
Precision for Medicine supports life sciences companies in the use of precision medicine by helping them design and execute clinical trials. They focus on biomarker-led strategies and have expertise in data science, clinical trial management, and laboratory services.
You will function as a central knowledge holder in a specialized team within Pharma Regulations & Audits.
You will carry out audits and compliance checks, formulate improvement measures and supervise the implementation.
You will implement projects to improve compliance and quality processes.
Redcare Pharmacy is Europe’s leading online pharmacy driven by innovative technologies and the passion of its employees. The company strives for an inspiring and collaborative work environment where everyone feels valued and contributes to their mission: “Until every human has their health.”
Conduct and report all types of onsite monitoring visits as well as remote visits.
Perform CRF review, source document verification and query resolution.
Be responsible for site communication and management.
PSI is a dynamic, global, mid-size company founded in 1995, bringing together more than 3,000 driven, dedicated, and passionate individuals. They work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Identify, structure, and execute funded research collaborations and clinical partnerships.
Translate scientific requirements into a site-friendly operational plan.
Ensure GDPR/HIPAA-aligned processes, DPAs, data minimization, and participant withdrawal workflow.
Cephalgo is a Strasbourg-based technology company founded in 2020, developing AI solutions for safety, compliance, and trust in human-AI interactions. Backed by over €3 million in funding, they combine expertise in voice AI, data protection, and compliance to help enterprises build responsible AI systems.
Responsible for delivery of site activation readiness within the assigned country/sites.
Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
Act as SME for collection and maintenance of site level critical path to Site Activation data points.
Precision Medicine Group is an organization that works in the medical field. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Serves as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track vera’s PV Risk Management obligations, commitments and proposed minimization measures.
Provide recommendations and guidance through subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide.
Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes.
Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. They aim to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Their values inspire employees every day.