job summary: The Director, Clinical Trial PV Operations will provide functional expertise and Program level oversight of outsourced PV Activities globally, including set up and conduct of clinical studies from a PV perspective, CRO training and management.Partners with key stakeholders within and outside PV to ensure continuous harmonized operations of global Pharmacovigilance activities and maintain highest standards for integrated functioning.Responsible for overall leadership to support global principles and standard practices for PV operational activities within clinical trials.Identify potential cross TA issues/risks in a proactive matter and lead discussions to mitigate themBe proactive in identifying any process gaps across TA and propose well thought out solutions and drive those solutions to implementations location: Cambridge, Massachusetts job type: Contract salary: $100 - 150 per hour work hours: 9 to 5 education: Bachelors responsibilities: Oversee outsourced PV Activities supporting clinical Trials at the clinical program levelPerform oversight tasks of daily study specific activities including SAE reconciliation, study set up, query management, SAE reconciliation, eTMF filing etc..Support study specific Inspection and Audit requestsBuild and foster cross functional relationships to promote and support PSPV standardsInfluence others and work collaboratively across functions to align on best practices and processesConduct sample quality review of outsourced activities including SAE Reconciliation, eTMF filling, SAE Forms and completion instructions, protocol safety section etc..Review Study level documents including Study Management Plans, Study Safety Summaries and SAE Reconciliation PlansMaintain direct contact with the study PV Operations Lead at the vendor to proactively identify risks and issuesSupport Study/program specific Audits and Inspections related to PV OperationsMaintain knowledge of PV Regulations and global industry practices for PV operational efficiency and complianceLiaise with and advise study teams including clinical Science, Data Management, Regulatory Affairs and other functional areas locally/globally on matters relating to Pharmacovigilance to ensure overall compliance and appropriate standards and methodologies within the companyEnsure consistency in collection, processing and evaluation of safety data, to drive improvements in company global processes.Represent Pharmacovigilance Operations on global Program/study teams qualifications: Bachelor's required. Degree in scientific/medical field or advanced degree preferred.previous experience working in global environment preferred.Minimum 10 years' experience in PharmacovigilanceMinimum 7 years' experience working with CROs, vendors, and relationship management preferred.Demonstrated skills in negotiation and consensus decision makingExpert knowledge of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements.Good cross-cultural understanding and experienceCritical thinking and analytical skills and ability to make high level decisions in cross- functional and global environments.Ability to review, analyze, interpret and present complex data to a high standardUnderstanding of and contribution to company business needs and global strategyAble 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.Good level of computer literacy with Microsoft applicationsExcellent organization skills and ability to prioritize individual and departmental workloads.Multi-tasking with the ability to successfully manage multiple critical issues simultaneouslyTake the initiative to patriciate in projects outside the direct remit of the job to enhance visibility of the department and ensure cross functional awareness of PSPV processes and standards. Some travel to global sites may be required. skills: Project Management, Pharmacovigilance, Drug Safety, CRO Oversight, Electronic Trial Master File (eTMF), Serious Adverse Event (SAE) Reporting Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.