Pharmacovigilance

Local Pharmacovigilance

Global Pharmacovigilance and Drug Safety Pharmacovigilance Pharmacovigilance Audits and Inspections
Medical team at PharmaRelations

Local Pharmacovigilance

Local Pharmacovigilance (PV) in the Nordics
We can provide local affiliate PV set-up and Local PV contact person in the Nordic countries: 
such as setting up the whole Quality Management System (QMS) from start or parts of it as applicable, perform case handling, local literature review, PV intelligence, management of additional Risk Minimisation Measures, reconciliation of potential AE sources, and more.

Our colleagues in Regulatory Affairs can provide you with all necessary local regulatory support to meet the different local regulatory requirements in the different Nordic countries.

Adverse Event/Reaction Management (Human and Veterinary)
We assist with collection, validation, triage, follow-up, data management including data entry into Eudravigilance (Human/VET), MedDRA/VeDDRA coding, quality management, evaluation, submission to partners/EV/MHRA portal, reconciliation and archiving. 

Danish and Norwegian PharmaRelations Country managers

Risk Management Plan and Risk Minimisation Measures
We provide strategic advice, creation, medical and regulatory review, update and submission of Risk Management Plan (RMP). 

We support with creation, implementation and tracking of Risk Minimization Measures (RMM).

Safety Physician, Advice
We can provide assistance with all safety physician tasks and roles all the way from medical review of regulatory documentation to global strategic safety and pharmacovigilance advisory roles, during the entire life cycle of your product.

Veterinary Surgeon
We can provide you with a veterinarian to support your company with 24/7 coverage, offering medicinal assessments of adverse events and signals, as well as addressing medicinal inquiries related to veterinary medicines.

Two medical consultants in hall

Pharmacovigilance (PV) QMS
We perform GAP-analyses of your PV QMS.
We set-up new PV QMS tailored to your needs, develop and maintain your existing PV QMS.
We create, update and maintain of Standard Operating Procedure (SOP), Working Instruction (WI) and Templates.

Business Continuity Plans (BCP)
We can assist with creating and maintaining a Business Continuity Plan as well as creating and performing BCP tests and Set-up of BCP risk assessment scheme.

Agreements
We can create, support, maintain Pharmacovigilance Agreements (PVA), Safety Data Exchange Agreements (SDEA), Master Service Agreements (MSA), etc.
We also help you with vendor assessment, negotiation, vendor selection, set-up and maintenance of contracts, vendor management.

Our Services

Interim Executives Due diligence PharmaRelations Academy Nordic market entry Audits Specialist recruitment Executive search Consulting & outsourcing Interim solutions

Expertise Areas

Cosmetics Supplements & Food Pharmaceuticals Quality Assurance Marketing Compliance Regulatory affairs
Medical Writing Medical Affairs
Data & Technology Digital & Social Media Sales & Marketing
Clinical development Pre-clinical services
Medical Engineering
Market Access
IVDR – In Vitro Diagnostic Regulation MDR – Medical Device Regulation ISO 13485 – Quality Management Systems Medical Device and IVD
Pharmacovigilance Audits and Inspections Local Pharmacovigilance Pharmacovigilance Global Pharmacovigilance and Drug Safety
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