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.
Assume leadership and functional representation for projects ensuring effective coordination and management of regulatory deliverables.
Perform quality control of regulatory intelligence screening and ensure maintenance of the regulatory intelligence database.
Provide regulatory strategic input to internal and external customers and promptly identify and address any risk.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They have achieved global organic growth year after year, with staff based across Europe, North America, and Asia, covering services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
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.
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.
Prepare, compile, and submit regulatory documents to IRBs/ECs
Support migration from Complion to Florence eRegulatory
Maintain CVs, licenses, and GCP documentation
UniTriTeam is a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Monitor updates to EP, USP, Mexico Ph, ChP, and JP.
Analyze changes in compendial requirements.
Ensure timely implementation of compendial changes.
Vertex Pharmaceuticals is focused on the discovery, development and commercialization of medicines. They strive to transform the lives of people with serious diseases.
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.
Establishes and maintains a document management system for regulatory electronic files.
Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.
Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients globally. They look for mission-driven candidates who want to advance the fight against cancer and make a difference in patients' lives.