P95 finds, collects, analyzes and reports epidemiological data to assist public health agencies, research organizations and pharmaceutical companies in improving peoples´ access to safe and effective vaccines.

Our vision is to be the world’s favorite global partner in the field of epidemiological research and pharmacovigilance, in support of vaccine development and use.

P95 offers a broad range of services in Epidemiology, Pharmacovigilance, Data Analytics, IT services, Medical Writing and Training.

Job purpose
The Study Data Manager is responsible for managing data management activities in the design, administration, data collection and lock of database for post-market surveillance studies but also for other types of studies (e.g., epidemiological studies). The Study Data Manager will play a key role in the project team and interface with research collaborators providing data and external vendors to fulfill many of his/her responsibilities.

Responsibilities
The roles and responsibilities for the Study Data Manager include, but are not limited to, the following:

• leading the development of data management capacity within P95,
• serving as the Lead Data Manager on multiple studies,
• implementing and supervising data management activities within assigned studies,
• developing data and database specifications for studies, including electronic and/or paper Case Report Form (CRF) design, user requirements, edit rules/checks, query logic and data validations,
• responsibility for double-data entry of existing paper CRFs,
• creating and maintaining project data management documentations (Data Management Plan, ),
• participating in the review of study research documents (eg. protocols, CRFs, reports and statistical analyses),
• contributing to the design of electronic data capture (EDC) systems,
• extracting and monitoring study data to identify issues,
• ensuring that the data is of good quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- including e.g., data reconciliation,
• participating in the preparation and presentation of data, when applicable,
• ensuring data system compliance by following the established guidelines of national and international regulatory authorities,
• participating in conference calls and/or meetings with research collaborators providing data and vendors, and
• mentoring or training other team

Experience:

The ideal candidate will have

• a Bachelor of Science (BSc) degree or higher, preferably in Health Sciences, Statistics, Informatics,
• working knowledge of ICH Good Clinical Practice (GCP) guidelines, clinical research, Good Epidemiological Practice (GEP) and other guidelines and standards related to study data management,
• ≥5 years of professional experience in relevant data management activities in the CRO or medical device/pharmaceutical industry,
• experience in leading clinical data management activities on clinical trial level and managing as well as supervising external CROs/vendors,
• experience in electronic data capture (EDC) systems,
• experience in monitoring and supervision of the set-up and maintenance of CDMS systems, eTools like EDC and filing and archiving of trial documentation,
• applicable knowledge in querying databases (SAS, SQL, R, others),
• experience in creation and execution of data quality checks,
• knowledge of industry data standards (CDISC, SDTM, CDASH), and
• excellent organisational skills.

You must also have these skills

• You are fluent in spoken and written English.
• You can work independently (remotely) and yet be a team player.
• You have a flexible approach to work.
• You are a self-starter, well organised and with attention to detail while keeping a “getting the job done” mentality.
• You are focused on delivering high-quality results on time.
• You are sensitive to cross-cultural differences.
• You have good communication skills.

What we offer
You will join a young, very dynamic, and fast-growing private research organisation. Our international, passionate, and diverse team consists of 60+ staff members, including epidemiologists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and office support staff spread over more than 10 countries. Our headquarters are in Leuven, Belgium but all our staff work remotely, setting their own time schedule, based on a “getting the job done” mentality. You may need to travel to our head office or to our client’s offices occasionally.

Working at P95 means an opportunity to work in a team on a project basis with ample room for professional development. We offer a lot of autonomy, flexibility and ample opportunities for research and development, to make things happen. We offer the opportunity to learn and evolve professionally. We consequently value self-reliance, initiative, and responsibility of everybody in our team to meet customer expectations. 

We offer you a full-time position. If you prefer a part-time job, we accept a minimum of 80% full-time equivalent (80% FTE).

For more information, contact our Head of Data Sciences, Kaatje Bollaerts: kaatje.bollaerts@p-95.com

P95 finds, collects, analyzes and reports epidemiological data to assist public health agencies, research organizations and pharmaceutical companies in improving peoples´ access to safe and effective vaccines.

Our vision is to be the world’s favorite global partner in the field of epidemiological research and pharmacovigilance, in support of vaccine development and use. We are continuously looking for nice, enthusiastic, and smart people.

P95 offers a broad range of services in Epidemiology, Pharmacovigilance, Data Analytics, IT services, Medical Writing and Training.

Job purpose
As IT expert, you will work with the other IT experts and IT engineers within P95 to support all P95 employees. The IT team closely collaborates with the team of statisticians. The IT expert reports to the IT Lead.

Responsibilities
The roles and responsibilities for the IT expert include, but are not limited to, the following:

• Setup end-user devices both manually as well as via automation
• Configuration, administration and support of Azure, MS O365, Windows 10/11 and Egnyte
• Able to support in end-user automation using Microsoft Intune, JAMP or similar environments
• Support both local server virtual environments as well as AWS/Azure environments. This includes server & storage setup.
• Provide Technical Support to end-users
• Provide support and input to the technical IT roadmap
• Architect and design new solutions
• Actively perform configurations / modifications in our applications and services
• Participate in the validation of these applications

Experience

The ideal candidate will

• Have at minimum a bachelor degree in IT or similar, with preferably a few years of relevant working experience
• Knowledge of or experience with GxP processes is an asset

You must also have these skills

• You have good command of written and spoken professional English.
• You can work independently (remotely) and yet be a team player.
• You are open to an agile way of working
• You are sensitive to cross-cultural differences.

What we offer
You will join a young, very dynamic, and fast-growing private research organisation. Our international, passionate, and diverse team consists of 60+ staff including epidemiologists, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and office support staff spread over more than 10 countries. Our headquarters are in Leuven, Belgium but all our staff work remotely, setting their own time schedule, based on a “getting the job done” mentality. You may need to travel to our head office or to our client’s offices occasionally. 

Working at P95 means an opportunity to work in a team on a project basis with ample room for professional development. We offer a lot of autonomy, flexibility and ample opportunities for research and development, to make things happen. We offer the opportunity to learn and evolve professionally. We consequently value self-reliance, initiative, and responsibility of everybody in our team to meet customer expectations. 

We offer you a full-time position. If you prefer a part-time job, we accept a minimum of 80% full-time equivalent (80% FTE).  

For more information, contact the it@p-95.com.

Do you want to join us?
Visit our website www.p-95.com to learn more about who we are and what we do. If you are the one for this job, send your application to jobs@p-95.com, adding ‘application IT expert’ to the subject line of your mail.  The call will remain open until the position is filled. Only candidates shortlisted for an interview will be contacted. Your CV is important, but we are specifically looking for the right people for our team.

P95 finds, collects, analyses and reports epidemiological data to assist public health agencies, research organizations and pharmaceutical companies in improving peoples´ access to safe and effective vaccines.

Our vision is to be the world’s favourite global partner in the field of epidemiological research and pharmacovigilance, in support of vaccine development and use. We are continuously looking for nice, enthusiastic, and smart people.

P95 offers a broad range of services in Epidemiology, Pharmacovigilance, Data Analytics, IT services, Medical Writing and Training.

Job purpose
To provide medical expertise to support all pharmacovigilance activities. To work on vaccine development and evaluation at all stages, covering most areas of pharmacovigilance, including medical reviews, signal detection and risk management.

Responsibilities

• To provide medical expertise in managing products or project teams, participating on cross-functional teams such as SOP committees, taskforces, work streams, processes and guidance to external business partners.
• To contribute to the development/preparation of protocols, investigator brochures, investigator letters, safety reports and clinical study reports, and lead the safety analyses of the assigned projects to ensure proper monitoring, collection, analysis and reporting of safety data.
• To monitor adverse events and provide medical assessment of adverse events and aggregate safety data. Identify, evaluate and escalate any trends and/or safety concerns.
• To provide medical expertise in routine and ad-hoc signal detection/management activities
• To drive the development, maintenance and implementation of Reference Safety Information for the assigned projects.
• To provide appropriate and timely Benefit Risk Assessments for assigned projects.
• To contribute to the design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation.
• To contribute to the development and review of pharmacovigilance processes and related training.
• To answer and follow-up of enquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects.
• To participate in meetings with internal or external safety boards (such as DSMB/IDMC).
• To contribute to the development of scientific publications based on the analyses and study results.

Experience

• You share a passion for pharmacovigilance and the drive to help our customers achieving their objectives 
• You have a medical degree
• You are fluent in spoken and written English 
• You have experience in the pharmaceutical or biotech industry working in clinical development, medical affairs, pharmacovigilance, drug safety or a related field
• Have notions of pharmacovigilance and signal detection tools, analysis and reporting of medical safety data/issues
• You have experience in ICSR handling procedures, SUSAR management, MedDRA mapping and coding, clinical trial oversight (required)
• You are familiar with post-marketing pharmacovigilance activities (advisable)
• You are able to work independently (remote), yet still in a team 
• You are sensitive to cross-cultural differences 
• You have good communication skills 
• You have a flexible approach to work 
• You are a self-starter, well organised and with attention to detail while keeping a “getting the job done” mentality. 
• You are focused on delivering high-quality results on time 

You must also have these skills

• fluent in spoken and written English,
• can work independently (remotely) and yet be a team player.
• have a flexible approach to work.
• self-starter, well organized and with attention to detail while keeping a “getting the job done” mentality.
• focused on delivering high-quality results on time.
• sensitive to cross-cultural differences.

What we offer
You will join a young, very dynamic, and fast-growing private research organisation. Our international, passionate, and diverse team consists of 100+ staff including epidemiologists, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and office support staff spread over more than 10 countries. Our headquarters are in Leuven, Belgium but all our staff work remotely, setting their own time schedule, based on a “getting the job done” mentality. You may need to travel to our head office or to our client’s offices occasionally. 

Working at P95 means an opportunity to work in a team on a project basis with ample room for professional development. We offer a lot of autonomy, flexibility and ample opportunities for research and development, to make things happen. We offer the opportunity to learn and evolve professionally. We consequently value self-reliance, initiative, and responsibility of everybody in our team to meet customer expectations. 

For more information, contact jobs@p-95.com

Do you want to join us?
Visit our website www.p-95.com to learn more about who we are and what we do. If you are the one for this job, send your application to jobs@p-95.com. The call will remain open until the position is filled. Only candidates shortlisted for an interview will be contacted. Your CV is important, but we are specifically looking for the right people for our team. Please write to us about why you would like to join us and how you see yourself contributing to P95.

P95 finds, collects, analyses and reports epidemiological data to assist public health agencies, research organizations and pharmaceutical companies in improving peoples´ access to safe and effective vaccines. 

Our vision is to be the world’s favourite global partner in the field of epidemiological research and pharmacovigilance, in support of vaccine development and use. We are continuously looking for nice, enthusiastic, and smart people.

P95 offers a broad range of services in Epidemiology, Pharmacovigilance, Data Analytics, IT services, Medical Writing and Training.

Job purpose
As Senior Epidemiologist, you will support and provide epidemiological expertise on diverse and multi-disciplinary projects. You will work on vaccine development and evaluation at all stages, covering most areas of epidemiology, including literature reviews, study design and implementation, conference presentations and publication writing.

Responsibilities
The responsibilities for the Senior Epidemiologist include, but are not limited to, the following:

• To support the design and development of study protocols as well as the planning and implementation of epidemiological studies
• To support the interpretation of study results and study reports
• To support the conduct of literature reviews, including systematic literature reviews
• To support manuscript preparation and submission
• To support the preparation of conference presentations
• To supervise and coach junior epidemiologists
• To present results to clients and in conferences as required
• To liaise with clients on specific projects as required
• To support project management tasks as required
• To support writing project proposals for clients as required

Experience
The ideal candidate will

• have at minimum an MD and/or PhD in Epidemiology (or equivalent experience); graduation from a recognized field epidemiology training programme (e.g. EPIET, EIS, ….) is an asset
• have at least 10 years of relevant working experience in epidemiology, preferably in a clinical research organisation or pharmaceutical industry,
• specific training/experience in infectious disease epidemiology, vaccine epidemiology and/or pharmacoepidemiology is an asset
• experience in Real World Evidence studies using electronic health records databases is an asset
• have a good command of written and spoken professional English.

You must also have these skills

• You have a keen eye for detail and good communication skills
• You have good command of written and spoken professional English.
• You can work independently (remotely) and yet be a team player.
• You have a flexible approach to work.
• You are a self-starter, well organised and with attention to detail while keeping a “getting the job done” mentality.
• You are focused on delivering high-quality results on time.
• You are sensitive to cross-cultural differences.

What we offer
You will join a young, very dynamic, and fast-growing private research organisation. Our international, passionate, and diverse team consists
of 100+ staff including epidemiologists, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and office support staff spread over more than 10 countries. Our headquarters are in Leuven, Belgium but all our staff work remotely, setting their own time schedule, based on a “getting the job done” mentality. You may need to travel to our head office or to our client’s offices occasionally.

Working at P95 means an opportunity to work in a team on a project basis with ample room for professional development. We offer a lot of autonomy,
flexibility and ample opportunities for research and development, to make things happen. We offer the opportunity to learn and evolve professionally. We consequently value self-reliance, initiative, and responsibility of everybody in our team to meet customer expectations. 

Do you want to join us?
Visit our website www.p-95.com to learn more about who we are and what we do. If you are the one for this job, send your application to jobs@p-95.com. The call will remain open until the position is filled. Only candidates shortlisted for an interview will be contacted. Your CV is important, but we are specifically looking for the right people for our team. Please write to us about why you would like to join us and how you see yourself contributing to P95.