Management of the Global Pharmacovigilance (GPV) CAPA process. Support the general work of the GPV group
Main Responsibilities
Oversight of the Deviation/CAPA process for GPV
Accountable for the objectives related to the GPV CAPA system
Act as CAPA database Subject Matter Expert and optimize use of the system within GPV
Ensure adequate documentation and training in relation to CAPA database and Deviation/CAPA management is provided to other GPV staff members / other Zoetis staff as appropriate
Create CAPA records and ensures that action items are completed in a timely manner
Monitor CAPA deliverables and facilitate completion via follow up with CAPA owners
Support Agency related topics such as PSMF and Agency Inspections in relation to GPV CAPAs
Partner with cross-functional stakeholders as appropriate to assure investigation are detailed, thorough and appropriate.
Other responsibilities
Contribute to the overall workload of the GPV group by taking on specific projects or responsibilities as necessary
Experience and background:
Demonstrated relevant experience gained in Global Pharmacovigilance or another regulated environment.
Experience with Mastercontrol or other CAPA management systems would be an advantage but is not essential.
Technical Skills Requirements:
At a minimum:
Detailed understanding of effective administrative support to colleagues / teams in a multicultural, dynamic and constantly changing learning environment.
High level of competency using Microsoft Office suite - with demonstrated high level competence of working in Microsoft Word and Excel.
Must be able to effectively communicate in English with colleagues at all levels of the organization and external regulatory agencies.
Consistently model behaviors of accountability and ownership through approachability, excellent interpersonal, communication, negotiation and problem-solving skills.
Ability to work independently, while fostering good working relationships across physical distance and have flexibility and the capacity to handle multiple tasks at once.
Attention to detail is critical to ensure that the expectations of all submissions to external agencies are met.
Able to demonstrate evidence of being a highly effective team player, be a problem solver with an ability to take ownership for issues with the ability to come up with creative solutions and implement them successful.
He/she will be able to influence without authority and support colleagues outside of GPV as the need arises.
Desirable
Experience of Pharmacovigilance Audits and Regulatory Inspections
Experience with Zoetis' Global Pharmacovigilance Database
Familiarity and experience with documentation of deviations and management of CAPA processes
Experience of dealing with Zoetis Regulatory Managers across all geographies
Experience with conducting Business Objects reports
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (Colorado). Base pay may vary based on location and other factors.
Base Pay Range: $61,000 - $87,000
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (California), (NJ Remote), (NY Remote), or (Washington). Base pay may vary based on location and other factors.
Base Pay Range: $69,000 - $99,000
[ This position is eligible for short-term incentive compensation.]
We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and
retirement savings benefits along with paid holidays, vacation and disability insurance.
Full time
Regular
Colleague
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