Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: Signal Detection, Pharmacovigilance, Quality Control, Record Keeping, Time Management
Company Description We are Ergomed group, a specialised mid-size service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North …
Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with st…
Skills: ICSR Management, Pharmacovigilance Case Processing, MedDRA Coding, WHO Coding, SAE/SUSAR Management
Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with …
Skills: Pharmacovigilance, Project Management, ICSR Processing, Aggregate Reports, Literature Screening
Company Description Medicine moves forward here. So will you. Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so …
Skills: Accounting, Financial Principles, Bank Reconciliation, Invoice Processing, Intercompany Activities
Company Description Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studi…
Skills: Biostatistics, Clinical Trial Design, SAS, R, Statistical Analysis Plan
Company Description Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studi…
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: ICSR Management, Pharmacovigilance, MedDRA Coding, WHO Coding, SAE/SUSAR Management
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: ICSR Management, Pharmacovigilance, MedDRA Coding, WHO Coding, SAE/SUSAR Management
Company Description Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studi…
Skills: Biostatistics, Clinical Trial Design, SAS, R, Statistical Analysis Plan
Company Description Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studi…
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: Case Processing, Pharmacovigilance, ICSR Management, SAE/SUSAR Management, Periodic Reporting
Company Description Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studi…
Skills: Biostatistics, Clinical Trial Design, Statistical Analysis Plan, SAS, R
Company Description Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studi…
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: Case Processing, Pharmacovigilance, ICSR Management, SAE/SUSAR Management, Periodic Reporting
Company Description Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studi…
Skills: Biostatistics, Clinical Trial Design, SAS, R, Statistical Analysis Plan
Company Description Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studi…
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: Case Processing, Pharmacovigilance, ICSR Management, SAE/SUSAR Management, Periodic Reporting
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Full-time
bachelor degree
Posted 25d ago
~40 hrs/week
Responsibilities
The officer is responsible for managing deviations and CAPAs within the department, collaborating with SMEs to conduct root cause analysis. They also drive audit and inspection readiness and review data to ensure continuous quality improvement.
Requirements
Requires a university degree in Biomedical sciences or relevant experience, with 2-3 years of pharmacovigilance experience including at least 2 years in ICSR. Prior experience in a Quality or Compliance role is mandatory.
Full job description
Company Description
Medicine moves forward here. So will you.
At PrimeVigilance, patient safety is not one part of the job. It is why we exist.
We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.
That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.
If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.
Job Description
Responsible for the deviations and CAPAs in their department, working with Subject Matter Experts (SMEs)
Supports SMEs to conduct root cause analysis or deviations and CAPAs
Ensures timely completion of actions
Acts as point of contact for delivery of audit and inspection CAPA preparation and delivery of actions within agreed timelines
Drives audit and inspection readiness within their department
Reviews data to drive continuous improvement and excellence in quality.
Delivers proactive department specific audit and inspection readiness training,
Works with department SMEs to arrange targeted interview practice
Contributes to development of training material for departmental quality
Ensures delivery of data required for quality and compliance metrics
Works closely with quality counterparts and head of department to drive improvement of departmental quality
Qualifications
Education:
University degree in Biomedical sciences, or relevant experience.
Experience:
2-3 years of work experience in pharmacovigilance with at least 2 years ICSR experience a necessity
Prior experience in a Quality and/or Compliance role is required
Problem Solving skills, approaching issues independently, and using one’s own initiative is necessary
Special Skills:
Experience of using an electronic Quality Management System desirable
Excellent communication (written and verbal) skills
Organization skills, including attention to details and multitasking
Delegation skills
Planning and time management
Technical skills
Team working
Language Skills:
Fluent in verbal and written English
PC Skills:
Advanced literacy (MS Office)
Additional Information
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
Quality: we hold ourselves to the standard patients deserve.
Integrity and trust: we do the right thing, especially when it is hard.
Drive and passion: we care about the outcome, because someone is waiting on it.
Agility and responsiveness: we move quickly, because patients cannot wait.
Belonging: everyone is welcome, and every voice counts.
Collaborative partnerships: we go further by going together.
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative clinical safety and PV services for pharmaceutical, biotechnology and medical device companies. Our leaders have an unrivalled reputation in the sector with a network of SMEs across the world. These include former senior regulators and consultants with expansive industry experience.
Offices: The Surrrey Research Park, 1 Occam Court, Guildford, Surrey GU2 7HJ, GB · Oreškovićeva ul. 6H, Zagreb, 10 020, HR · Đorđa Stanojevića 14, Novi Beograd, 11 070, RS · Herriotstr. 1,, Frankfurt am Main, Frankfurt 60528, DE · Václavské náměstí 2132/47, Flow Building, Prague, Prague 1 110 00, CZ
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative clinical safety and PV services for pharmaceutical, biotechnology and medical device companies. Our leaders have an unrivalled reputation in the sector with a network of SMEs across the world. These include former senior regulators and consultants with expansive industry experience.
Offices: The Surrrey Research Park, 1 Occam Court, Guildford, Surrey GU2 7HJ, GB · Oreškovićeva ul. 6H, Zagreb, 10 020, HR · Đorđa Stanojevića 14, Novi Beograd, 11 070, RS · Herriotstr. 1,, Frankfurt am Main, Frankfurt 60528, DE · Václavské náměstí 2132/47, Flow Building, Prague, Prague 1 110 00, CZ