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Corporate Audit, Senior Manager GCP/PV Auditor

Pfizer


Location:
Groton, CT
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

**ROLE SUMMARY**



The Senior Manager - Corporate Audit is responsible for planning and conducting independent audit and risk oversight activities related to the areas of GCP and Pharmacovigilance primarily, as well as GLP, GMP and Animal Welfare. These audits provide an independent assessment of the design and operating effectiveness of controls and compliance with appropriate regulations, internal policies and procedures and good business practices. Additionally, this individual interfaces with business representatives and makes recommendations on oversight approaches for risk mitigation.







**ROLE RESPONSIBILITIES**



**Audits**



1. Provides fact-based input into the risk assessment of audit targets and conducts scheduled audits in accordance with Corporate Audit processes.



2. Conducts other oversight activities (e.g. Assessments, due diligence, compliance investigations) as assigned.



3. Identifies ways to improve audit processes to ensure appropriate assessments of controls in an evolving business model.







**Analysis**



1. Recommends approaches for oversight activities to mitigate risks across the assigned business line.



2. Identifies ways to improve oversight and assessment processes.







**Relationship Management**



1. Works within functional area to ensure consistency in approach and to minimize gaps and redundancies in activities.



2. Cultivates strong relationships within Corporate Audit to achieve an effective oversight program.



3. Uses compliance and business intelligence to forge relationships critical to a comprehensive oversight program.







**Other Activities**



1. Maintains high level of awareness of changing needs of the business, industry trends, competitive activities and regulatory environment.



2. Takes on special projects at the request of management.



3. Serves on Corporate Audit departmental committees/teams, as necessary.



4. Assists in the development/updating of Corporate Audit departmental standard operating and administrative procedures.



5. Serves as a resource on GCP or PV compliance matters.







**QUALIFICATIONS**







+ Bachelor's degree in a scientific discipline (e.g. Biology, Chemistry, Nursing, Medical Technology, Pharmacy). Advanced degree preferred.



+ Five or more years of relevant GCP US and International operational experience in clinical development, and/or Pharmacovigilance experience required.



+ Previous audit experience preferred.



+ A thorough understanding of GCP and/or Pharmacovigilance global regulations and demonstrated subject matter expertise.



+ Demonstrated ability to apply knowledge of regulations, policies and standards to assess compliance.



+ Demonstrated good project management skills.



+ Experience working in dynamic complex business models (e.g. outsourcing and partnerships)



+ Ability to assess systems and processes in a highly systematic manner and make conclusions based on sound judgment and experience in order to identify gaps and potential risk.







Excellent written and verbal communication and presentation skills.



Excellent interpersonal and negotiation skills, with a demonstrated ability to effectively interact with clients, influence others, identify compliance gaps, and communicate pathways for corrective/preventative actions.



Ability to create a strong collaborative environment working with all levels of management.



A self-starter who holds themselves and others accountable.



Ability to travel (both domestic and international) up to 40%.







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**







**Travel requirements 40%**







**Additional Offer Details:**







+ **Last Date to Apply for Job: 11/10/2017**



+ **Grade:13**



+ Eligible for Employee Referral Bonus: Yes







**EEO & Employment Eligibility**



Pfizer 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. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.







**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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