Pharmacovigilance Process Manager

Spectra force • Northbrook, IL, United States • $200k - $250k / year • 1w ago

Title: Pharmacovigilance Process Manager
Location: Northbrook, IL 60062
Duration: 2 Years
PR: $60-64/hour
Description

Responsible for defining standards for PV process related matter and procedure in line with global PV process strategy.
Development and maintenance of global standards and processes for case processing and related activities.
Responsible to define standards for AE intake requirements.
Continuously assess processes and identify opportunities to improve efficiency, effectiveness and compliance.
Able to lead projects to the implementation of process improvements.
Manage planned and unplanned deviations and ensure accurate periodic review.
Assist with setting standards, decision making and maintenance of product specific case handling conventions in consultation with PV Process Management
Management for Argus system changes to ensure accurate and timely assessment of impact to global PV process
Liaison with PV functional teams (Medical Safety Science) for impact of process changes.
Perform impact analysis for global regulatory intelligence results
Maintain standards and procedures for identification and management of Product Quality Complaints associated with safety information coordination with other PV functions and QA units related to triage, case processing, investigation, reconciliation and reporting.
Assist PV Process as SME during audits and inspections

Requirement:

Minimum MSc in life sciences
Minimum of 7 years relevant experience in PV or combined PV/RA/QA and/or clinical development
Extensive PV knowledge
Strong interpersonal skills and multicultural awareness;
Able to lead complex process improvement projects
Able to negotiate and build consensus for plans and priorities and develop effective relationships through collaboration
Able to make decisions and involves management at the right moment
Excellent oral and written communication skills in English, with an ability to interact with all levels of personnel, and global SMEs.
Demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across global organization.
Able to interpret, execute and recommend changes to established policies and programs
Leadership, decision making and negotiation skills
Strong analytical skills
Six Sigma or similar process improvement methodology knowledge a plus