Offer summary

Qualifications:

University degree in medicine, pharmacy, or life sciences., Minimum 2 years of experience in pharmacovigilance post-marketing activities., Up-to-date knowledge of global and local regulatory requirements., Fluency in written and spoken English..

Key responsabilities:

Act as the primary point of contact for local regulatory authorities.

Monitor changes to local legislation and safety issues related to client products.

Support client audits and inspections, including documentation and CAPAs.

Provide monthly activity reports on the status of the local pharmacovigilance system.

Job description

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are currently expanding our global PV network and looking for passionate individuals with experience across local pharmacovigilance. The LCPPV coordinates and performs the logistical aspects of pharmacovigilance activities in clinical trials and post-marketed programs to ensure an effective and accurate collection, database entry, review and reporting of safety data for Allucent Pharmacovigilance activities. This position controls and monitors operational pharmacovigilance activities and may back-up Pharmacovigilance Manager(s) as required.

This role can be based in any European Country however you must reside in the local country.

Key Requirements

University degree, preferably in medicine, pharmacy or life sciences and minimum 2 years of experience in the performance of pharmacovigilance post-marketing activities

Have up-to-date knowledge of applicable global and local regulatory requirements
In-depth knowledge of the pharmacovigilance legal framework in country where LCPPV services are delivered
Fluency in the written and spoken English language
Reside in the country where LCPPV provides services

Requirements

Acts as the primary point of contact for the local regulatory authorities, including 24/7 if legally required

Provides a deputy for coverage in case of absence

Monitors and maintains awareness of changes to local legislation pertaining to pharmacovigilance

Monitors and maintains awareness of safety issues and recommendations published by the local regulatory authorities, concerning the client products or products class

Supports client audits and inspections, as required, including attendance, provision of requested documentation and completion of Corrective Actions and Preventive Actions (CAPAs), if needed

Also key responsibility for;

local literature screening
collection of safety information
local submissions, if applicable
the development or the review of the local pharmacovigilance system master file (LPSMF), if required
local signal detection, if applicable
Manage locally any risk minimization measures, as applicable
Report to and maintain regular communication with the EU QPPV
for review of local PV agreements, if requested
local PV training to eg. sales force, affiliate personnel, distributors
Provides monthly activity report on status of local PV system

Required profile