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Pharmacovigilance Clinical Operations Manager

Kelly Services

Cambridge, MA 02238
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Job Details

Kelly Services is **URGENTLY seeking an experienced Pharmacovigilance Clinical Operations Manager for a one-year assignment in Cambridge, MA** . The PV Clinical Operations Manager supports oversight of pharmacovigilance (PV) activities in clinical trials, ensures compliance with global pharmacovigilance requirements, supports GCP and PV inspections and audits and through oversight of outsourced activities, ensures all pharmacovigilance lead activities are executed consistently throughout all pre- and post-approval Clinical Studies globally.

This is not PV case processing. To qualify for this position candidates must have been part of a study team representing PV, reviewed protocols and SOWs, drafted/authored SMP and/or SSPs, unblinded data for SUSAR reporting, reviewed CRFs and worked with EDC and TMF.

The PV Operations Manager is responsible for:

+ Supporting partner / vendor oversight in relation to Clinical Trial PV Operations and collaboration with other functions (e.g., Clinical Operations, Global Medical, Data Management, Medical Writing, Regulatory, Biostatistics, and others) to ensure consistency with regulations and with departmental goals and objectives

+ Ensuring regulatory compliance with safety regulations globally and fulfills the pharmacovigilance obligations for its global programs

+ Ensuring productive and effective collaboration across functions responsible for clinical trial delivery

+ Ensuring timely support for safety issues & inquiries impacting global programs

+ Supporting strategies for compliance with relevant Regulatory Agencies on pharmacovigilance requirements and gaining consensus within Global PV Safety

+ Ensuring effective coordination of trial safety logistics globally, drawing input from relevant lead product safety physicians and trials safety managers

+ Monitoring Purchase Orders and ensuring that invoices from vendors are within the scope of the budgeted activities.

+ Contributing to the development and maintenance of pharmacovigilance processes

+ Supporting and maintaining a state of inspection readiness


+ Bachelors degree required; advance degree preferred

+ Must have significant Clinical Trial Operations experience from the PV perspective including representing PV on a Clinical Study Team, protocol and SOW review, author SMP and SSPs

+ Demonstrated skills in negotiation and consensus decision making

+ Expert knowledge of clinical trial and pharmacovigilance methodologies

+ Critical thinking and analytical skills and ability to make and communicate high level decisions or complex data in cross-functional and global environments

+ Understanding of and contribution to business needs and global strategy

+ Able to interact with personnel from all functional areas and externally to the company at all levels and to represent the department and company in a highly professional manner

+ Project Management abilities

+ Excellent ability to work under high pressure and to manage both time and priority constraints and to manage multiple priorities simultaneously

+ Attention to details, computer literacy, knowledge of EDC and TMF

+ Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

Perks of being a Kelly employee:

Weekly electronic pay

Access to more than 3,000 online training courses though Kelly Learning center

Group rate insurance options available immediate upon hire*

Service bonus plan and holiday pay*

Online application system

Never an applicant fee

*perks to be received upon meeting eligibility requirements

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.

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

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect
with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
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