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. 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. 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. 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. 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…
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. 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…
Skills: Biostatistics, Clinical Trial Design, Statistical Analysis Plan, SAS, R
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. 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. Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so …
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 …
Sarajevo, Federation of Bosnia and Herzegovina, Bosnia and Herzegovina · Remote OK
Entry level
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 …
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: English Proficiency, Japanese Proficiency, MS Office, Excel, Word
Sarajevo, Federation of Bosnia and Herzegovina, Bosnia and Herzegovina · Remote OK
Entry level
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 …
Sarajevo, Federation of Bosnia and Herzegovina, Bosnia and Herzegovina · On-site
Mid level
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 …
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 …
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Full-time
bachelor degree
Posted 28d ago
~40 hrs/week
Responsibilities
The role involves processing Individual Case Safety Reports from various sources in compliance with regulations and client requirements. Additionally, the officer manages SAE/SUSAR submissions and mentors junior employees within the department.
Requirements
Candidates must hold a degree in life sciences or a healthcare-related field and possess several years of demonstrated experience in pharmacovigilance case processing. Advanced English skills (C1 level) and strong organizational abilities are required.
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
At PrimeVigilance, PV Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability.
If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them.
The PV Officer should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) and have demonstrated experience with several years in case processing. The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.
Responsibilities include:
Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review.
Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.)
Mentoring and training of new and more junior employees within the department, including procedure optimization and development
Qualifications
Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing
Demonstrated case processing experience
Time and issue management, delegation, organization and multitasking skills with good attention to detail
Strong interpersonal and communication skills
Advanced English skills, both verbal and written, at least C1
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