MAIN PURPOSE OF ROLE:
Well versed with most updated PV Guidelines and all aspects of Signal detection and Safety aggregate reports.
Has good data review experience and worked on signal detection.
Work actively in identifying and processing signals for all Concordia products as been assigned.
Managing the compliance and quality of signal detection.
Literature search for signal detection activity.
Accountable for signal detection and submission of verified signals.
Keeping abreast of changing PV requirements across Europe and Rest of World
Contribute towards continued improvement of safety systems and processes
Ensure all documentation is structured and maintained as required
Provide regular PV training to members of the Drug Safety team as well as the Company
Working on Signal detection.
Comply with PV regulations and Company procedures.
Interaction with Regulators, patients and prescribers from a safety perspective if required.
Ensure PV systems are in line with industry standards.
Compliance with GPvP requirements, demonstrated through audits and inspections.
Support to the business and provision of documentation within agreed timeframes.
Successful relationships with all external partners.
Address internal and external inspection findings.