Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and ...
Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and ...
Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and ...
Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and ...
Primevigilance information
What are the key skills and qualifications needed to thrive in the Primevigilance position, and why are they important?
To thrive in a Pharmacovigilance Specialist role at PrimeVigilance, you need a solid background in life sciences or pharmacy, knowledge of drug safety regulations, and experience with pharmacovigilance processes. Proficiency with safety databases (such as Argus or ARISg), standard coding systems (MedDRA, WHO-DRUG), and relevant certifications like a PV certification or GVP training are highly valuable. Excellent attention to detail, strong analytical thinking, written communication skills, and the ability to work collaboratively stand out in this position. These skills ensure the accuracy and integrity of safety data, compliance with regulatory standards, and effective teamwork in monitoring the safety of medicinal products.
What are some typical daily responsibilities of a Pharmacovigilance Specialist at PrimeVigilance?
Pharmacovigilance Specialists at PrimeVigilance are responsible for processing and evaluating adverse event reports, performing case assessments, writing and submitting regulatory reports, and maintaining accurate drug safety documentation. The role involves communicating with healthcare professionals, clients, and regulatory authorities to clarify or follow up on safety information. On a daily basis, you will use safety databases and coding systems to ensure data accuracy and consistency while contributing to ongoing risk management activities. This position typically works as part of a multidisciplinary team and offers opportunities to collaborate with medical writers, regulatory experts, and clinical research professionals.
What is a Primevigilance job?
A Primevigilance job typically involves roles in pharmacovigilance, which focuses on drug safety and monitoring adverse effects of pharmaceutical products. Professionals in this field assess and report adverse drug reactions (ADRs), ensure regulatory compliance, and contribute to risk management. Roles may include drug safety associates, medical reviewers, and regulatory specialists. These jobs are crucial for maintaining patient safety and supporting healthcare professionals with accurate drug safety data.
What cities are hiring for Primevigilance jobs? Cities with the most Primevigilance job openings:
What job categories do people searching Primevigilance jobs look for? The top searched job categories for Primevigilance jobs are:
Job description
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 they experience more of life's meaningful moments. Biopharmaceutical companies are our clients. Patients are our purpose.
Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and other complex areas of medicine. Across the Group, our teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world.
The science and analysis that guides our work is demanding. And this is where we excel. What defines us, though, is how we work together. Across countries, cultures and time zones, we bring kindness, curiosity and a shared sense of purpose to work that genuinely matters. Ideas are welcome here. Growth is expected. And every person has room to make a real difference to patients' lives.
Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are. If that sounds like the place you have been looking for, we would love to hear from you.
Job Description
- Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study
- Identifies the investigators and verifiesthat the investigator has adequate qualifications,resources, facilities, equipment and staff toconduct the clinical study throughout the study period.
- Trains investigational site staff as necessary
- When applicable, supports preparation of regulatory and / or EC submissions
- Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.
Qualifications
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials in oncology or rare disease
- Full working proficiency in English
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel nationally
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.
We look forward to welcoming your application.
About ERGOMED
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
1 - 10 Employees
Headquarters location
San Antonio, TX, US
Year founded
1987