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22 days old

Pharmacovigilance Audit Specialist

Kelly Services
Bridgewater, NJ 08807
**Pharmacovigilance Audit Specialist**


Kelly Services has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for a Pharmacovigilance Audit Specialist with our client, a leader in the medical device industry, located in Bridgewater, New Jersey.


Hybrid role- 3 days, on-site 2 days remote


Until the end of the year LIKELY to extend


**Responsibilities**


+ Supports in the preparation and follow-up of any internal or external audits and/or regulatory inspections impacting Pharmacovigilance from announcement until closure.

+ Ensures that companies audit and/or inspection readiness activities comply with the business partnership agreement and/or regulatory obligations, specific to pharmacovigilance.

+ Active involvement in the organization of appropriate support for the preparation and follow-up of Global PV Quality audits or Business Partner audits impacting global PV processes, until closure.

+ Ensure completion of audit/inspections PV related Corrective and Preventive Actions CAPAs to ensure timely completion and effectiveness to prevent a recurrence.

+ Assists in all audit preparation activities, including the development of a CAPA plan.

+ Responsible for the inclusion of audit responses in the audit/CAPA system.

+ Responsible for the close-out of any audit action items.

+ Participating in the ongoing permanent inspection preparedness and readiness of GPRM and country PV offices in anticipation of Regulatory inspections and audits.

+ Active involvement in the preparation and follow-up of regulatory inspections impacting PV until closure.

+ Support external relations with Inspectorates / Agencies / Pharma associations to ensure surveillance of PV regulations in the field of PV inspections and benchmark on recurrent PV findings.

+ Interaction with internal/external stakeholders and/or 3rd Party Service Providers to address and close-out audit findings to ensure compliance


**Requirements**


+ Bachelors Degree preferably in a life sciences healthcare-related discipline with a strong experience in pharmacovigilance or clinical safety-related area with experience in quality-related activities.

+ Minimum of 4 years in the pharmaceutical or life sciences industry with a focus on PV operations, quality, and compliance in a global environment.

+ Excellent knowledge of International ICH/CIOMS, EU Good PV practices, and FDA regulations in the domain of Pharmacovigilance.

+ Ability to work well in a matrixed, global team environment.

+ Knowledge of Quality or Deviation Management software would be a plus

+ Demonstrates expertise related to understanding the principles and application of PV quality and regulatory compliance.

+ Knowledge of Auditing and drug safety within pharmaceuticals.

+ Demonstrates ability to effectively communicate and influence the outcomes of the decision-making process.

+ May conduct presentations on quality issues, initiatives, and cross-functional functional meetings.

+ Ability to build relationships with key internal and external customers.

+ Excellent attention to detail and ability to work under pressure.

+ Extensive knowledge of MS Office applications and systems.

+ Proven results and solutions-orientated.

+ Excellent organizational and project management skills.

+ Outstanding written, verbal, and interpersonal communication skills.

+ Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment.

+ Enthusiastic with an ability to be flexible and adaptable and drive change to meet the needs of an expanding department


Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-06-06 Expires: 2022-07-07

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Pharmacovigilance Audit Specialist

Kelly Services
Bridgewater, NJ 08807

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