Pharmacovigilance Quality Assurance Lead
Pharmacovigilance Quality Assurance Lead
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1 Vacancy
Job Description
Role Description
As the Pharmacovigilance (PV) Quality Assurance Team Lead within the Regulatory Affairs Global Quality & Compliance (GQC) group oversee the Quality Assurance (QA) PV program for Zoetis. Continuously develop and drive the strategy for quality and regulatory compliance within the program. Within this role instill a philosophy of risk balance consistency and efficiency within the Zoetis community Global Pharmacovigilance and other stakeholders of the company.
As a leader within the GQC group provide quality assurance oversight to the global PV program. Be the point of contact for pharmacovigilance QA ensuring alignment and open communication with US and European Pharmacovigilance teams and other stakeholders of the program. Lead the daytoday GQC PV operational activities including the scheduling of GQC PV auditing activities (process audits distributor and Zoetis Country Office audits). Be proficient in performing pharmacovigilance quality assurance audits and inspections of Veterinary Medicine Research & Development (VMRD) PV processes as well as those PV processes which reside outside the VMRD organization (e.g. country offices distributors). Take a lead QA role in the management of CAPA and deviation activities for pharmacovigilance operations. Participate in government inspections of the pharmacovigilance program and others types of inspections as requested. Provide advice on regulatory and corporate compliance as well as provide evaluations of current practices that may need improvements. Provide novel approaches to increasing effectiveness of both the GQC group and the quality and compliance of VMRD. Interact effectively with VMRD managers and their staff as an advisor on the interpretation of compliance aspects. Supervise GQC colleagues and contractors who participate in PV audits. Be responsible for meeting company driven deadlines for conducting performance evaluations colleague development planning and other required supervisory roles. Assist the GQC Global Lead with budgetary planning and monitoring activities. Where appropriate assist with staff recruitment and training. Participate in a variety of quality assurancerelated activities including staff and project meetings nonresearch study document reviews and consultations with VMRD colleagues. Take a lead role in participating in VMRD meetings specifically GQC PV meetings projects and ad hoc committees for quality initiatives. Communicate (verbal and written) well with VMRD colleagues management level individuals and external parties (e.g. distributors CROs vendors). Ability to effectively represent the company or the GQC group in externalfacing situations.
EDUCATIONAL BACKGROUND/EXPERIENCE
MINIMUM:
- Bachelors Degree or equivalent in biology animal science or other relevant science field.
DESIRABLE:
- Masters degree or equivalent in biology animal science or other relevant science field.
WORKS EXPERIENCE/SKILLS
MINIMUM:
- Demonstrated relevant auditing experience (minimum 5 years) in veterinary pharmacovigilance or related regulatory environment.
- Experience with deviation/CAPA processes and associated documentation.
- Experience in managing people.
- High level of competency using Microsoft Office suite (e.g. Word Excel Outlook).
- Establishment of excellent interpersonal relations; good communications; ability to negotiate risk assess and problemsolve.
- Ability to work independently while fostering good working relationships across physical distance and have flexibility and the capacity to handle multiple tasks at once.
- Ability to travel if needed.
DESIRABLE:
- 10 years working in a research quality assurance field supporting animal health trials.
- 5 years in managing people.
- Experience in conducting pharmacovigilance audits and participating in regulatory inspections.
- Experience in working with pharmacovigilance databases.
- Proficiency in the understanding of current regulatory requirements regarding the quality of research for registration of animal products in major global markets.
- Proficiency in performing quality assurance audits and inspections of nonclinical and clinical veterinary product studies and reports (including protocols data/data listings statistics master study files final study reports clinical investigator study sites and inphase inspections) and of facilities CROs and processes that support those studies.
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.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at to request an accommodation. Zoetis also complies with all applicable national state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: 1 our company website at site or 2 via email to/from addresses using only the Zoetis domain of @. In addition Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.Employment Type
Full-Time
