flag

CHOOSE COUNTRY

Regulatory affairs

Pharmacovigilance

DAYFOTOGRAFI-PR2022-0517
DAYFOTOGRAFI-PR2022-0217

WE ARE A FULL-SERVICE PARTNER WITHIN PHARMACOVIGILANCE (PV)/ DRUG SAFETY.

As the market leader within the Nordic region we can provide you with any solutions needed for your PV system.

We can offer you skilled and experienced junior, mid and senior consultants part-time, full-time, or in recruitment into your company.


Our clients vary from small, to medium to big global life science companies and the assignments can vary from national, and regional to global responsibilities.


We cover competencies within both human and veterinarian pharmaceuticals, medical devices, cosmetics, and food supplements.

Pharmacovigilance

OUR SERVICES

  • Set-up, development and maintenance of PV system incl. QMS
  • EU and UK QPPV, dQPPV, local responsible PV person
  • 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
  • Gap analysis
  • PV intelligence
  • Training
  • PSMF
  • PSUR, DSUR
  • RMP, RMM
  • Line management, Mentorship

DAYFOTOGRAFI-PR2022-0202

Full, part time, per hour, per proyect solutions

Qualified Person responsible for Pharmacovigilance

Provision of QPPV, deputy QPPV.

Medically Trained Person

Provision of Physician or Veterinarian including 24/7 coverage.

National Contact person for PV

Provision of National Contact person for PV.

Audit

Audit of your PV System, Local Affiliate, Partner or Service Provider. Creation of Audit Strategy, Riskbased Planning and Program.

DAYFOTOGRAFI-PR2022-0435

Inspection

Inspection readiness. Support before, during and after your Competent Authority Inspection by a former PV Inspector.

PV System

Gap analysis, set-up, development and maintenance of your PV System.

Quality System

Gap analysis, set-up, development and maintenance of your Quality Management System (QMS).

PV System Master File  (PSMF)

Creation, update and maintenance of the PSMF.

DAYFOTOGRAFI-PR2022-0502

Written Instructions

Creation, update and maintenance of Standard Operating Procedure (SOP), Working Instruction (WI) and Templates etc.

Signal Management

Signal evaluation and handling including Signal Detection, Validation, Assessment, Prioritization and Actions.

Risk Management

Creation, update and submission of Risk Management Plan (RMP). Creation, implementation and tracking of Risk Minimization Measures (RMM).

Aggregate Reports

Creation and submission of periodic safety reports such as Periodic Safety Update Report (PSUR) and Annual Report (AR).

DAYFOTOGRAFI-PR2022-0220

Computerized systems

User Requirement Specification (URS), due diligence, Computer System Validation (CSV).

Literature Search

Global and Local literature search.

Contracts

Vendor assessment, negotiation, set-up and maintenance of contracts, vendor management.

Case handling

Collection, validation, triage, follow-up, data management, coding, quality management, evaluation, submission and archiving.

This website use cookiesfor statistic and user experience.

Pharmarelations uses cookies to improve your user experience, to give basis for improvement and further development of the website and to be able to direct more relevant offers to you. Please read our personal data policy. If you agree to our use, select Allow All. If you want to change your choice afterwards, you will find that option at the bottom of the page.

Cookies