Pharmacovigilance 

A partner that combines local expertise with a global reach to meet compliance requirements.

Safety doesn’t happen by chance. It happens by vigilance.

A solid extension of your pharma or biotech safety team for both full a PV system and a local safety network across Europe and emerging markets (CIS & EAEU). Our pharmacovigilance team combines modern technology with decades of experience to the highest compliance levels in the industry.

They anticipate your business growth and offer both local expertise as well as up-to-date knowledge of global regulations. The team is fit to handle large Post-Authorization projects and well-suited to tend to small and medium biopharma in clinical development. We often integrate our Pharmacovigilance services with our Medical Information and Regulatory Affairs services, working efficiently as a multi-disciplinary team.

Clinical Trials

 

Biomapas team experts are able to provide clinical safety service in a wide range of therapeutic areas and product classes, starting from clinical safety set-up, going to continuous surveillance of the study and finalizing with study closure activities. Our experienced team offers fast and reliable safety management plan development and smooth execution. We ensure efficient safety database set-up, including individual tenant environment set-up, specific case attributes and data migration. Clinical Safety

Medical Monitoring

 

 

 

PV System & QPPV

Biomapas supports Marketing Authorisation Holders and Applicants in the fulfillment of all pharmacovigilance obligations regarding medicinal products, including the establishment and maintenance of Pharmacovigilance System, and offers experienced EU Qualified Person for Pharmacovigilance to take responisiblity of your pharmacovigilance affairs.

 

 

 

 

 

 

Pharmacovigilance System set-up & QPPV

PSMF Development & Maintenance

RMP Development & Maintenance

EAEU-QPPV

National QPPV

Pharmacovigilance Database

Pharmacovigilance Auditing

Post-Authorization

We offer all necessary global, comprehensive drug safety services to complete or entirely outsource your pharmacovigilance activities. Our expert team members, who hold degrees in medicine and pharmacy, maintain consistent case processing according to all EMA requirements while recording cases in Safety Database with supreme at least four-eye quality check and assessment.

 

Local Pharmacovigilance Operations

Global and Local Literature Screening

 

 

 

Geographical Coverage

Veeva Safety Database

Clinical Trials

Biomapas team experts are able to provide clinical safety service in a wide range of therapeutic areas and product classes, starting from clinical safety set-up, going to continuous surveillance of the study and finalizing with study closure activities. Our experienced team offers fast and reliable safety management plan development and smooth execution. We ensure efficient safety database set-up, including individual tenant environment set-up, specific case attributes and data migration.

Clinical Safety

Medical Monitoring

PV System & QPPV

Biomapas supports Marketing Authorisation Holders and Applicants in the fulfillment of all pharmacovigilance obligations regarding medicinal products, including the establishment and maintenance of Pharmacovigilance System, and offers experienced EU Qualified Person for Pharmacovigilance to take responisiblity of your pharmacovigilance affairs.

Pharmacovigilance System set-up & QPPV

PSMF Development & Maintenance

RMP Development & Maintenance

EAEU-QPPV

National QPPV

Pharmacovigilance Database

Pharmacovigilance Auditing

Post-Authorization

We offer all necessary global, comprehensive drug safety services to complete or entirely outsource your pharmacovigilance activities. Our expert team members, who hold degrees in medicine and pharmacy, maintain consistent case processing according to all EMA requirements while recording cases in Safety Database with supreme at least four-eye quality check and assessment.

Local Pharmacovigilance Operations

Global and Local Literature Screening

Geographical Coverage

Veeva Safety Database

PV Professionals

%

Medical Doctors

Countries covered

QPPV & LPPV Network

Inhouse experienced EU QPPVs and a network throughout Europe to comply with local requirements.

In-house Workforce

Not another middleman, working through own workforce across Europe and CIS

Integrated Solutions

We combine our Medical Information expertise with RA & PV in multi-disciplinary teams.

Blog

MAH is the Key to the Pharmacovigilance

Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers (HCP), pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder (MAH).

A Global Player That Understands Local Nuances In Hard-To-Reach Regions 

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Martijn van de Leur

Martijn van de Leur

Head of Global Pharmacovigilance

Martijn van de Leur has over 15 years of experience in pharmacovigilance. Throughout his career in big pharma, Martijn went from entry-level positions in safety data management to senior medical advisory roles within the Clinical Risk Management teams. He also helped his companies to develop their PV systems through multiple massive company merger integration projects. Before joining Biomapas, Martijn held several executive roles as (Deputy) EU QPPV, Global Head of PV Compliance and Global Head of PV Technologies.