Anticipated role level: Senior Associate
Role has two main functions:
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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