Processes ICSRs according to SOPs and project-specific safety plans.
Enters data into Argus Safety Database and codes events, medical history, and meds.
Generates timely expedited regulatory reports and ensures safety report distribution.
Precision Medicine Group is expanding its capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru. They are an Equal Opportunity Employer that values diversity and inclusivity.
Providing strategy based on regulatory requirements.
Completing regulatory and PV deliverables based on established plan.
Acting as Local Contact Person for Pharmacovigilance for designated country.
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 and value employee experience, well-being and mental health.
Act as the Person Responsible for Regulatory Compliance (PRRC) under EU Medical Device Regulation (MDR).
Partner closely with Product, Engineering, Machine Learning and Data, Customer Care and Legal teams.
Help build and strengthen Docplanner's regulatory framework, directly supporting EU MDR compliance and global expansion.
Docplanner Group's mission is to help people live longer, healthier lives. As the world’s largest healthcare platform, they connect 24 million patients with 280k doctors across 13 countries. Docplanner's marketplaces, SaaS and AI tools simplify daily tasks and help doctors, clinics and hospitals work more efficiently.
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.
Monitor and own the progress of clinical studies at investigative sites.
Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. They have a strong focus on Oncology and Rare Disease and passionate about cultivating their culture with high CRA retention rates.
Assists in the maintenance of structures and processes which support improvement and patient safety.
Uses clinical knowledge in formal and informal consultation with individual staff, clinicians and managers, to address clinical quality and safety concerns.
Participates in clinical adverse event task groups.
Dartmouth Health is a nationally recognized Academic Medical Center set in the White Mountains of New Hampshire, stretching over New Hampshire and Vermont. They offer a rigorous, research-focused environment and are anchored by the academic Dartmouth Hitchcock Medical Center in Lebanon, NH.
Preparation and submission of regulatory dossiers.
Advise on strategies and registration requirements for product development and marketed products.
Lead regulatory assessment and actions for changes to product and QMS processes.
Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. They have more than 10,000 colleagues and provide products and services in around 90 countries, promising to be forever caring.
Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
Perform quality control of regulatory intelligence screening of legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
Provide internal teams and Clients with expertise and guidance on national requirements.
Ergomed Group is a rapidly expanding global full-service mid-sized CRO specializing in Oncology and Rare Disease. The company includes the more specialised brands- PrimeVigilance, Adamas Consulting and Ergomed CRO and values employee experience, well-being and mental health.
Independently oversees all aspects of study site management to ensure patient safety is protected.
Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits.
Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image.
Precision Medicine Group is expanding its capabilities across Latin America. 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.
Serve as the global leader for Immunovant product safety.
Provide strategic vision and operational oversight across all aspects of drug safety.
Lead all pre- and post-marketing safety, PV and risk management activities.
Immunovant is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.