IQVIA Manager of Pharmacovigilance Operations (Office-Based) - NCR in Cambridge, Massachusetts
Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
General Scope and Summary
XXXX is searching for an experienced Manager of Pharmacovigilance (PV) Operations that is a creative, resourceful, integrative thinker. The Manager of Pharmacovigilance Operations will work on projects and processes that ensures the strategies of the department are executed within global safety legislation and requirements. The successful candidate will have a proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency. Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Operations, Medical Science, Data Science, Regulatory Affairs and Quality Systems and Medical Affairs.
Roles and Responsibilities
Participates in the review and execution of PV Operations safety data collection strategy across clinical trial and commercial programs
Provides oversight and review of vendor case processing activities
Responsible for participating in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs for all XXXX products
Provides knowledge into Clinical and Post Marketing teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into XXXX studies and commercial activities/programs that may generate adverse event data
Participates in the creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents
Accountable for reconciliation activities between Global Patient Safety and Post Marketing programs to ensure reporting of all adverse event data
Actively participates in cross functional projects that develop and support strong cross-functional relationships and communication
Maintains knowledge of adverse event reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods
Contributes to projects which involve the implementation of new processes and methods within and across Global Patient Safety
Undertake activities necessary to maintain a state of inspection readiness
Provides sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans
Actively participates in the quality review of SAEs and SUSARs following data entry by vendor. Specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, and appropriateness of queries to seek follow-up from the clinical sites
Represents Drug Safety and Pharmacovigilance on clinical development teams, as assigned
Participates in internal audits and global regulatory inspections including MHRA/FDA/EMA etc. as a SME for specific PV topics and processes as needed
Experience, Education and Specialized Knowledge and Skills
Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences required
Master’s degree in health care related profession preferred, but not essential
5-7 years of direct “hands on” Drug Safety and Pharmacovigilance experience
Vendor management experience
Knowledge of FDA, ICH, EU Regulations and Requirements for Pharmacovigilance
Experience using ARISg, Argus or other Safety Database applications required
Strong analytical and problem-solving skills with excellent attention to detail
Strong verbal, written technical communication and presentation skills
Proficiency in standard desktop software programs (Word, Excel, Outlook)
Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
Excitement about the vision and mission of XXXX
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.