Global Pharmacovigilance Senior Associate and CAPA System Business Owner

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.

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.