Pharmacovigilance

The evolution of research and medicine has allowed us to develop new and more effective drugs for the treatment of mild ailments and complex pathologies.
But pharmaceutical products can cause side effects.
That’s why pharma companies are required to adopt a compliant pharmacovigilance system to control the risk-benefit balance of their products.

Do you want your processes to comply with regulatory provisions while still being efficient and effective?

How can my company achieve compliance?

PQE Group, thanks to the vast 25+ years of experience in LifeSciences can support
Pharma Companies and Marketing Authorization Holder approaching the regulations
to solve compliance related issues at global level.

Quality Assurance for Pharmacovigilance

QA support

We offer advanced solutions for Quality and Compliance in GVP area, supporting individual client needs in finding the most effective solutions and services to meet regulatory requirements, reach their goals and improve processes.

Set up and Maintenance of Pharmacovigilance System (PSMF)

PQE can provide author, review or provide support in preparing a PSMF in preparation for product application/authorisation in the EU. If a PSMF is already in place, PQE can provide support in  reviewing and updating as required.

SOP Pharmacovigilance / Safety Procedure writing

We have extensive experience in developing Pharmacovigilance operating procedures such as Standard Operating Procedures (SOPs) and Working Instructions. We also provide assistance with the review and update of existing procedures.

Audits

At PQE, we offer a worldwide audit service. With our teams of local experts, we enable companies to optimise their resources, improving the time and scope of each audit. Our service ensure the comfort and ease of the process managed by a single consultant of PQE.

Trainings

Analysis and assessment of training needs. We can perform induction/ongoing/refresh training to all company staff and Pharmacovigilance staff specific training to support stakeholders in meeting their pharmacovigilance obligations.

Audit and inspection readiness

Preparation and post inspection support for remediation actions.

CAPA, deviation, change management

Our team will provide investigation and CAPA support within your quality system and will help you optimize your processes.

KPI monitoring

PQE experts can provide support and advice in setting up and monitoring KPI’s.

Computer System Validation

We support our customers in planning, conducting, reviewing and maintaining the validation status of their application through GxP assessment, validation planning, user requirements analysis and authoring and execution including validation report.

Pharmacovigilance System and processes

Case processing & Reporting

  • Receipt and triage of initial and follow-up cases SAEs, SUSARs, ICSRs, regulatory cases 
  • Data entry 
  • MedDRA coding 
  • Narrative production 
  • Analysis of duplicates 
  • Case Quality Control 
  • Medical Assessment 
  • Case closure and locking 
  • Generation and distribution of follow-up queries 
  • Global expedited case reporting 
  • EudraVigilance reporting using EV Web and E2B (R3) compliance 
  • Reporting to Competent Authorities 
  • Reconciliation with external data collection partners (CROs, affiliates, partners, etc.) 

Literature search and Review

We will manage scientific literature search to establish the most significant source of information in monitoring the safety profile and the risk-benefit balance of medicinal products. This is particularly relevant in relation to detecting new or emerging safety signals or issues.

Periodic Reporting

We are experts in safety reports and can support you in their preparation, submission, assessment and monitoring.

Signal Management

  • Signal detection 
  • Signal analysis and validation 
  • Confirmation and prioritisation 
  • Assessment 
  • Recommendation for action and communication

Risk Management Plan

We can support in writing the Risk Management Plan that is required for most of the products as part of a marketing authorization application.

Responding to enquiries from Competent Authorities

Experienced PQE staff will interface with regulatory authorities and sponsors to ensure that any safety issues that arise are managed efficiently and pragmatically.

Regulatory Intelligence

PQE provides instant access to regulatory insights and real-time updates from national authorities across the globe, helping you to avoid the resource-intensive process of gathering, organizing, and sharing important regulatory information.

Acting QPPV and Deputy QPPV

We support pharmaceutical companies with a full suite of services, including acting QPPV and deputy QPPV for pharmacovigilance: 

  • QPPV and/or Deputy services 
  • Availability 24hrs/7days and business continuity

EudraVigilance registration and XEVMPD submissions

We can assist with the registration into the EudraVigilance system in order to fulfil the ICSR electronic reporting requirements in E2B format as well the submission of data into the extended EudraVigilance Medicinal Product Dictionary (XEVMPD).

Local Contact Person for Pharmacovigilance

Our professionals are well qualified to cover the role of LCP for Pharmacovigilance and to liaise with local authorities on behalf of our customers.

Preparation of Safety Data Exchange Agreements (SDEAs)

We can support companies to develop agreememts that define the responsibilities of each partner with respect to each of the pharmacovigilance activities. A professionally written SDEA ensures regulatory compliance and avoids duplication of pharmacovigilance activities by different partners.

Join the family.

Marketing Authorisation Holders and Applicants, Local Representatives, Distributors, Vendors and CROs, Sponsors and Competent Authority all chose PQE Group as their Pharmacovigilance support provider.

Don’t wait, achieve compliance today.