Otsuka Pharmaceutical Companies (U.S.) · 1 day ago
Senior Manager, Compliance & Business Management
Princeton, NJ
Full-time
Onsite
Mid, Senior Level
$135K/yr - $201K/yr
2+ years expOtsuka Pharmaceutical Companies is a global leader in the pharmaceutical industry, and they are seeking a Senior Manager for their Global Pharmacovigilance Compliance & Business Management. The role involves supporting the development and implementation of compliance processes within the pharmacovigilance organization, ensuring adherence to global regulations, and managing compliance activities and metrics.
Health CareMedical
Responsibilities
Responsible for supporting the development and maintenance of Pharmacovigilance Agreements (PVAs)
Responsible for ensuring compliance with global, local and regional PV regulations and policies/procedures and take corrective and/or preventive actions, when needed and as applicable to PVAs
Support PV audits/inspections and assist in developing CAPAs in response to findings/observations in relation to PVAs and compliance
Manage routine compliance metrics in pharmacovigilance activities related to PVAs
Perform impact analysis regarding PV compliance strategies and work instructions including input into PVAs
Participate in the root cause analysis, identification and investigation of non-adherence (deviations) to PV requirements in accordance with the PVA or PVA processes
Facilitate round table reviews/comments resolution meetings as needed
Support other GPVAM activities as applicable
Responsible for compiling compliance metrics according to local and regional PV regulations and Otsuka's policies/procedures and to request implementation of corrective and/or preventive actions, when needed
Ensure implementation of relevant updates to PV regulations to the impacted tasks in scope of the role, within the required timeline
Develop and implement metrics and dashboards to ensure regulatory requirements for PV are compiled and risks are minimized
Facilitate early detection of potential compliance through trend analyses and subsequent timely reporting to the relevant regional stakeholders (e.g. in Europe the EU-QPPV has to be included)
Responsible for driving automation and innovation in compliance monitoring
Attend Global / Regional meetings as required
Present compliance metrics at Global Meetings
Contribute to maintenance of PV System Master File as required
May be assigned to lead or assist with special projects or process development
May perform any other duties as needed
Qualification
Required
Bachelor's degree
Expertise in Good Pharmacovigilance Practice (GPvP)
Technical skills & experience
Minimum 2 years PV Compliance or Quality Management experience in the pharmaceutical industry
Microsoft proficient
Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance
Solid background and experience in pharmaceutical quality system management (GxP)
Experience with participation in PV audits in the pharmaceutical industry
Strong project management, interpersonal, communication and presentation skills
Ability to accomplish objectives through influence in a matrix organization
Strong computer skills with Word, Excel, PowerPoint, and Outlook
Excellent written and verbal communication with internal and external customers
Excellent planning and organizational skills
Strong collaboration and self-leadership skills
Adapt business acumen in decision making
Ability to work autonomously, take accountability for actions
Benefits
Comprehensive medical, dental, vision, prescription drug coverage
Company provided basic life
Accidental death & dismemberment
Short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
A generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Other company provided benefits
Company
Otsuka Pharmaceutical Companies (U.S.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Tarek Rabah
President & CEO
Reza Moghadam
Co-founder and lead for PsychU (www.PsychU.org)
Recent News
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