Job Abstract

Job Description

Are you looking for an exciting opportunity with a growing pharmaceutical

manufacturer? If so, then this is the opportunity for you!

Responsible to support PV Quality System audits 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 our company's Animal Health Policies and Procedures.

Job description

• Responsible to support and participated in planning and co-ordination of pharmacovigilance (PV) audit activities within our company and externally with CRO’s, laboratories, contactors and external business partners

• 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 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 two (2) 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 one (1) year 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.

VETJOBS

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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, generally Tuesday, Wednesday and either Monday or 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”.

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Expected 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.

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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. 

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