Job Description
The Position
Under the direction and oversight of the Executive Director, Drug Safety, the Case Management ICSR Quality Reviewer maintains and performs the necessary processes to ensure high quality and compliant reporting of individual case safety reports in accordance with PV regulations. The Case Management ICSR Quality Reviewer monitors the quality of individual case reporting to ensure internal and regulatory compliance.
Responsibilities:
Perform retrospective quality review of different types of case reports such as Post Marketing Surveillance (PMS), Hospital discharge summaries, Spontaneous and Literature reports processed.
To check accuracy all data entered in OARS including coding of adverse event reports, Narrative, labeling and causality, Relatedness/Expectedness assessment in compliance with SOPs and regulatory requirements.
Participate in team meeting, training of the team, and contribute towards process and quality improvement, and compliance, and process harmonization.
Preparing & sharing quality reports with operational team on a regular basis, contribution in RCA/CAPA of quality nonconformance.
Partner with internal and external stakeholders to identify, prioritize and monitor quality and compliance issues and develop solutions to minimize risk and ensure the overall quality management system. Implement emerging regulations to ensure global alignment of quality and compliance activities and processes.
Assess the impact of internal procedural changes to quality and compliance monitoring activities and update of these activities to remain relevant.
Maintain procedural documents relevant to quality review and compliance activities.
Participate in inspection readiness activities and preparation as needed
Assist in the review of responses to regulatory agency questions with regards to quality and compliance monitoring activities.
Develop and maintain tools to streamline the monitoring of quality and compliance, introducing automation where possible.
Partner with cross-functional stakeholders in the development, review and execution of SOP and supportive documents related to ICSR business processes.
Assist ICSR Process owner in the implementation of new or updated regulations and/or ICH Guidelines to ensure regulatory compliance for individual case safety reports. Provide support to activities essential to supporting updates and maintenance of the safety database.
Participate and support in various important pharmacovigilance processes, IT and quality initiatives contributing to continuous process improvement of ICSR management and innovative solutions.
Collaborates internally and externally on processes that ensure compliance with local and global PV regulations.
Assist in training and mentorship for internal and external stakeholders.
Support other PV Operations related tasks as and when required.
Tasks
Retrospective quality review of case reports.
Check accuracy of data entered in OARS.
Participate in team meetings, training of team, process and quality improvement, and process harmonization.
Prepare and share quality reports with operational team, contribute to RCA/CAPA of quality nonconformance.
Lead Quality Review Cycles (Case Assignment, Sample Review, Tracking and Finalizing cycles), facilitate Quality Review feedback between Data Entry site and ICSR Quality Review Team. Approve case corrections and revisions when appropriate.
Provide input in the development of quality management system for ICSR processing including appropriate metrics for both Compliance and audit readiness.
Provide expert guidance to those activities essential to supporting updates and maintenance of the safety database.
Lead and participate in various important pharmacovigilance processes, IT and quality initiatives contributing to continuous process improvement of ICSR management and innovative solutions.
ICSR Training and mentorship.
Query and SME support
Data and Quality Trend analysis with action plans to address the same.
Required Education, Experience and Skills:
Bachelor's degree or master's degree in a life science/health care/pharmaceutical related field.
Minimum of 3 years of experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities related to individual case safety reporting.
Previous experience with Pharmacovigilance and PV system (preferably Argus) and quality review activities.
Knowledge of PV principles, systems, and requirements in addition to PV regulations.
Strong analytical skills and quality focus Problem solving, conflict resolution and critical thinking skills.
Ability to function with a high degree of autonomy, quickly adapt to changes in business priorities and effectively manage competing priorities.
Demonstrated ability to build and manage close relationships with key stakeholders within the region.
Proficient in basic Office 365 suite applications.
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Relocation:
VISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings: