Job Description
The Position
The Aggregate Safety Process, Sr Specialist maintains and performs the necessary processes to ensure high quality and compliant reporting of aggregate safety reports in accordance with PV regulations.
Responsibilities:
Perform quality review and compliance monitoring of aggregate safety reports to Health Authorities and Business Partners adhering to regulatory requirements.
Measure quality effectiveness by tracking appropriate metrics and evaluating key performance indicators.
Responsible for extracting, calculating and overall QC of patient exposure for aggregate reports.
monitors the quality of aggregate safety reports and compliant reporting to ensure internal and regulatory compliance.
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 of aggregate safety reports.
Extract, calculate and quality review of patient exposure data.
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.
Participate in various important pharmacovigilance processes, IT and quality initiatives.
Maintain procedural documents relevant to quality review and compliance
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
Provide training and support to new team members
Management of Aggregate Report operations of mailbox
Contribute to continuous improvement efforts in the process
Required Education, Experience, and Skills:
Bachelor's degree or master's degree in a life science/health care/pharmaceutical related field
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.
Proficient in basic Office 365 suite applications
Strong English written and verbal communication skills
Ability to organize and multi-task with attention to detail
Strong working knowledge of Microsoft Office and IT tools used for assigned process
Analytical skills to manage process data, metrics and KPIs
Ability to collaborate well with others and develop effective relationships, motivate and influence in a cross-functional environment
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: