Summary of Job Position:

The Pharmacovigilance Officer (PV Officer) will collect, register and evaluate all safety information that emerges from PV activities during post-marketing uses of medicinal products.

Experience Required:

A minimum of 1 years experience within a similar position

Duties required:

- Act as a Qualified Person for PV/Local Contact Person for PV (QPPV/CPPV) or Deputy (as required), of marketed products, supporting the clients according to general/local regulation and specific needs
- Management and follow-up of Adverse Events (AEs): report forms, assessment, causality, registration, Quality Control (QC) and submission activities meeting the set deadlines
- Management and follow-up of the medical information enquiries received: answers, registration, QC and possible AEs detected, sending to the clients meeting the set deadlines
- Perform internal training on PV for the company team and external trainings of the clients according to SOP
- Notify the client and the Competent Authorities (CAs) of any reported Serious Adverse Event (SAE), meeting the requested due date
- Ensure that all information related to product’s safety is notified to the CA.
- Perform (as required) the literature research for the specific substances and trade names for the products included in PV agreements
- Support the QPPV with the preparation and maintaining of the PV System Master File (PSMF)
- Prepare the Risk Management Plan (RMP) for marketed products
- Ensure 24/7 hours PV availability to the clients
- Revise and update the PV calendar monthly for each product
- Make PSURs when needed and support their submission to the CAs
- Support the QPPV in maintenance of the EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) for the medicinal products of the clients
- Give support to the QPPV about any Direct Healthcare Professional Communications (DHPCs) to be prepared and distributed in Spain




- Support the QPPV in performing the European PV Regulatory Monitoring considering the PV regulations and the safety information published by EU RAs related to the products monitored for the clients
- Perform the Spanish PV Regulatory Monitoring considering the PV regulations and the safety information published by the AEMPS related to the products monitored for the clients
- Preparation of safety concerns documentation in relationship with Marketing Authorization (MA) application and renewals
- Calculate the Key Performance Indicators (KPI) of the Department
- Prepare and update the SOPs and working instructions of the clients if required
- Prepare and maintain the PV SOPs, Manuals, Plans, Annexes and records of the Department
- Maintain the PV archiving of the Department and complete the file forms to be checked by the QPPV/CPPV for each project
- Revise the Safety Data Exchange Agreement (SDEA) for each client
- Attend internal and external audits/inspections to the Department and support the preparation of the audit/inspection responses with the HeadPV/QPPV/CPPV and the QA department of the company
- Support in the monthly reconciliation reports (when needed)
- Support performing some administrative duties like service orders and the monthly invoicing when it is needed

Education and skills required:

- Degree in Life Sciences or similar.
- Specific education on PV (Master will be desirable).
- Working knowledge of Microsoft Office package.
- Organizational and teamwork skills
- Knowledge of at least one PV Data Base
- English level: high

Position available with hybrid-style working. 3 days per week in office, 2 days remote. If you are not located in Madrid but located in Spain and still wish to apply, please feel free to enquire as long as you hold the relevant experience.

Job Type: Full-time

Pay: 22,000.00€ - 32,000.00€ per year

Experience:

- Post Marketing PV: 1 year (Required)
- QPPV: 1 year (Preferred)

Language:

- English (Preferred)

Location:

- 28023 Madrid, Madrid provincia (Preferred)

Work Location: In person

📌 Pharmacovigilance Officer (PV Officer) (Madrid)
🏢 QualitecFarma
📍 Madrid