Job Description
*Prepare & ensure the implementation of systems & SOP's in adherence to Good pharmacovigilance practices, 21 CFR part 11& EU annex 11 for computer systems.
* Identify opportunities for improvement and develop strategies aimed at simplifying processes and improvng quality of outputs while ensuring compliance with regulatory requirements.
*Independently review, evaluate, approve proposed corrective and preventative action plans (CAPA)in collaboration with the PV team and track them.
*Ensure that documents describing the quality systems are subject to document control in relation to their creation, revision, approval & implementation.
*Prepare the facilitating internal audits, external audits, health authority Pharmacovigilance inspections, assess results of pre inspection activities and HA inspection findings in terms of associated risks and communicate to management
* Identify training needs for PV and business partners supporting PV and conduct appropriate trainings
*To support Pharmacovigilance team and other business partners with compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement.
* Experience working with case processing
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Legal, Regulatory, Intellectual Property
Role Category: Regulatory Affairs Manager
Role: Regulatory Affairs Manager
Keyskills: Pharmacovigilance, Quality Managemnt, Computer system validation, case processing, compliance investigation, PV