Kelly Services Pharmacovigilance Clinical Operations Manager in Cambridge, Massachusetts
Kelly Services is urgently seeking a Pharmacovigilance Clinical Operations Manager for a one-year assignment in Cambridge, MA . This role supports oversight of pharmacovigilance activities in clinical trials, ensures compliance with global pharmacovigilance requirements, supports GCP and PV inspections and audits. Through oversight of outsourced activities, ensures all pharmacovigilance lead activities are executed consistently throughout all pre- and post-approval Clinical Studies globally.
The PV Operations Manager is responsible for:
Supporting partner / vendor oversight in relation to Clinical Trial Pharmacovigilance 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
Liaising with the relevant lead product safety MD as appropriate
Ensuring timely support for safety issues & enquiries impacting global programs
Supporting strategies for compliance with relevant Regulatory Agencies on pharmacovigilance requirements and gaining consensus within Global PV Safety
Ensuring effective co-ordination 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
Bachelor’s 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 SSP’s
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, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll 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 career—connect 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 kellyservices.com 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.