Job Description

Responsible to support PV Quality System audits at our company's Animal Health own sites/entities, CROs and system audits. Support to monitor all aspects of the operational business comply with GXP legal and Regulatory Requirements and the company's Animal Health Policies and Procedures.

Job description

• Responsible for planning and co-ordination of pharmacovigilance (PV) audit activities within our company and externally with CRO's, laboratories, contactors, and external business partners

• Perform and Support PV audits as required.

• Review and Approve Corrective and Preventive Actions (CAPA)s which are necessary due to audit findings.

• Assure maintenance of audit data in a related data system (incl. reports and follow-up of audits)

• Co-ordinate the planning of PV Audit training sessions, and compilation of PV Audit Risk Assessments (e.g., for Supplier Qualification)

• Support our company's Animal Health sites in their preparation for Regulatory Agency Inspections by conducting audits, "Mock Inspections", training and other support activities.

• Support the conduct effective "Due Diligence" activities of potential in-licensed products, acquisitions and partners as required.

• Identify and report critical and major quality and compliance risks and gaps during audit activities.

• Ensure effective follow-up audits of sites with significant quality and compliance issues.

• Support the conduct effective "For Cause" audits to investigate frequent field alerts, recalls, rejects and complaints.

• Support in informing Senior Management of emerging regulatory and PV trends to help avoid compliance risks.

• Provide effective support during regulatory inspections as requested by QA.

• Willing to travel extensively and on short-term off-site assignments for remediation projects based on business needs.

Qualifications

Requirements:

• A bachelor's degree in a Scientific Discipline/Life Sciences or related discipline. A master's degree in a relevant discipline or higher degree preferred.

• A minimum of ten (10) years of pharmaceutical industry experience in a compliance-related area (e.g. PV, QA, Auditing, work in GLP, GCP, GMP environments), with a minimum of five (5) years' experience in Quality Assurance/Auditing/Pharmacovigilance.

• Excellent interpersonal skills, i.e., ability to build constructive relationships, positive & constructive attitude, desire, and ability to work in interdisciplinary teams.

• Very good organizational, communication, and negotiating skills.

• Very good written and verbal communication skills in English.

• Ability to facilitate and/or lead a variety of meeting formats.

• Ability to perform in a multi-task and multi-cultural environment.

• Good computer skills.

• Preferred Experience and Skills: Working knowledge of global pharmacovigilance procedures preferred.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R322538