Pharmacovigilance

Pharmacovigilance

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PHARMACOVIGILANCE (PV)/ DRUG SAFETY.

We have patient safety and quality at heart. Our high standards are maintained and realized by our experienced and knowledgeable personnel, which among others holds experience from the MPA PV inspectorate as well as PRAC, NOMA, MPA, EMA and WHO.

We support human and veterinary pharmacovigilance (PV) during the whole product life cycle: for example clinical safety, pre-authorisation, post-marketing PV, de-registrations and Marketing Authorisation transfers.

We offer skilled and experienced junior, mid-, and senior consultants part-time, full-time, short or long-term assignments, covering a role or assist in recruitment within pharmacovigilance for your company.

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OUR SERVICES: Customized PV Support

We have experience from small to large pharmaceutical companies, covering national, EU or global responsibilities.

We will customize our pharmacovigilance and drug safety services according to your specific requirements and level of support needed.

Examples of PV areas where we can support YOU:

    Set-up, development and maintenance of global PV system incl. QMS
    EU and UK QPPV (incl. deputy), local responsible PV person
    Local Pharmacovigilance set-up and maintenance
    Medically trained person: Physician, Veterinarian
    Audit strategy, riskbased planning, program and plan
    Audit of your PV system, local affiliate, partner or service provider
    Inspection readiness and support
    PV intelligence
    Training
    PSMF
    PSUR, DSUR
    RMP, RMM
    Management, mentorship

 


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