
1001 - 5000 employees
Founded 1997
đź Consulting
đĽ Healthcare
đŚ Logistics
Consulting ⢠Healthcare ⢠Logistics
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
đĽ 16 hours ago
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1001 - 5000 employees
Founded 1997
đź Consulting
đĽ Healthcare
đŚ Logistics
Consulting ⢠Healthcare ⢠Logistics
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
⢠Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client requirements, and timelines ⢠Perform ICSR follow-up activities ⢠Manage SAEs/SUSARs, including unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review ⢠Perform clinical and partner reconciliation ⢠Handle personal data protection activities ⢠Handle Product Quality Complaints and interact with Quality Assurance ⢠Interact with Medical Information ⢠Perform MedDRA and WHO coding ⢠Produce database outputs and reports, including monthly client reporting data ⢠Manage workflow and resources ⢠Support pharmacovigilance processes related to ICSR management within PrimeVigilance and for clients ⢠Perform tasks assigned to more junior positions, where applicable for a more senior colleague ⢠Support the RA & PV Network Department as needed ⢠Act as LCPPV for the specified country and PRLS for the designated language, as agreed with the line manager
⢠Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance ⢠Minimum 1 year of work experience in pharmacovigilance ⢠Organization skills, including attention to detail and multitasking ⢠Management skills, including time and issue management ⢠Advanced English, spoken and written ⢠Advanced literacy in MS Office ⢠Ability to act as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country, as agreed with the line manager ⢠Ability to take on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager
⢠Remote work option ⢠Flexible work environment ⢠Growth opportunities ⢠Collaborative team environment ⢠Belonging and inclusive culture ⢠Opportunity to work on global pharmacovigilance projects ⢠Professional development through work with clinical research, pharmacovigilance, and quality consulting experts
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