Boehringer Ingelheim Pharmacovigilance Mgr - Clinical Support in RIDGEFIELD, Connecticut
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
Responsible for implementing and maintaining global reporting practices for clinical adverse events, including, data collection and delivery, reconciliation and medical terminology coding. Provide support to Global Pharmacovigilance (GPV) and Clinical Development and Operations, Data Management and Drug Regulatory Affairs in areas of adverse event report management. Determine and communicate impact of clinical trial programs on GPV resources.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
Develop common processes for SAE data collection and delivery, reconciliation, drug and event coding, adverse event reporting and resource planning in collaboration with Data Management, Clinical Operations, Clinical Development and Drug Regulatory Affairs.
Collect and analyze data on clinical projects for use in GPV resource planning.
Act as subject matter expert in areas of clinical trial adverse event collection, processing and regulatory reporting.
Collaborate with Medical Safety group to confirm accuracy of adverse event information reported and collected.
Participating in the study development and startup activities. Communicate complex safety related issues to management
Participate in departmental projects/activities as deemed appropriate. Provide support to case processing teams where appropriate.
BS degree (required) in nursing, pharmacy or related health care field; MS or higher degree in nursing, pharmacy or related health care field (preferred)
Minimum of three years of relevant clinical practice in an acute care setting (preferred)
Minimum of three to five years pharmaceutical industry experience (required) with two years experience processing adverse event information(preferred)
Working knowledge of FDA regulations(preferred)
Ability to make decisions independently
Ability to prioritize workload and perform under stress in situations in which working speed and sustained attention are critical aspects of the job.
Application of medical knowledge to collect, interpret and reconcile medical information in order to precisely capture the adverse event as reported.
Must be able to communicate and resolve issues effectively with inter/intra departments through strong interpersonal skills.
Proficient in electronic data capture tools (e.g. ARISg) and Microsoft-based applications.
Must have problem solving skills and the ability to organize time effectively.
Must be legally authorized to work in the United States without restriction.
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Organization: US-BI Pharma/BI USA
Title: Pharmacovigilance Mgr - Clinical Support
Location: Americas-United States-CT-Ridgefield
Requisition ID: 187125