Pharmacovigilance Project Manager - UBCUnited BioSource Corporation (UBC) - PA, USA
Brief Description:Lead UBC pharmacovigilance project teams to deliver project milestones and oversee all aspects of the safety project conduct from start-up through close-out.Specific Job Duties:Oversee all aspects of the safety project conduct from Start-up through Close-OutManage project per the scope of work and within the contracted budgetReview contracts and ensure that change orders are issued, as necessaryDevelop plans to achieve contracted milestones (i.e. ...
Lead UBC pharmacovigilance project teams to deliver project milestones and oversee all aspects of the safety project conduct from start-up through close-out.
Specific Job Duties:
Oversee all aspects of the safety project conduct from Start-up through Close-Out
Manage project per the scope of work and within the contracted budget
Review contracts and ensure that change orders are issued, as necessary
Develop plans to achieve contracted milestones (i.e., Adverse Event Reporting Plan, Safety Data Management Plan)
Ensure project specific staff training and associated documentation
Prepare project timelines and project management related deliverables
Identify percent complete units for monthly revenue recognition meeting with Finance as well as forecast future unit completion
Ensure project budget is tracked against contract milestones
Present project information at bid defenses, client meetings and UBC project review meetings
Assist in project specific audit preparation and actively participate to the audit
Ensure full documentation of project files
Matrix supervision of project team
Bachelor, MSc or equivalent
5 years direct project management experience at a CRO or pharmaceutical company and/ or 2 or more years of pharmacovigilance experience
Demonstrated knowledge of pharmacovigilance regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
Demonstrated supervisory skills
Excellent interpersonal and presentation skills
ABOUT THE DEPARTMENT
United BioSource Corporation (UBC), a subsidiary of Express Scripts, is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
UBC aligns with Accredo and CuraScript SD, also part of the Express Scripts family, to provide best-in-class, integrated services.
ABOUT EXPRESS SCRIPTS
Advance your career with the company that makes it easier for people to choose better health.
Express Scripts is a leading healthcare company serving tens of millions of consumers. We are looking for individuals who are passionate, creative and committed to creating systems and service solutions that promote better health outcomes. Join the company that Fortune magazine ranked as one of the Most Admired Companies in the pharmacy category. Then, use your intelligence, creativity, integrity and hard work to help us enhance our products and services. We offer a highly competitive base salary and a comprehensive benefits program, including medical, prescription drug, dental, vision, 401(k) with company match, life insurance, paid time off, tuition assistance and an employee stock purchase plan.
Express Scripts is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, national origin, age, veteran status, disability, or any other protected class. Applicants must be able to pass a drug test and background investigation. Express Scripts is a VEVRAA Federal Contractor.
10 days 16 hours ago
United BioSource Corporation (UBC)
applyPharmacovigilance Project Manager - UBC United BioSource Corporation (UBC) - , PA, United States
In 2003, we started United BioSource Corporation because we saw unprecedented changes occurring within the health care market that would fundamentally and permanently affect companies that develop and market drugs and devices. We saw increasing government and payor scrutiny of marketing practices. We saw rising fear around the costs of new medications. We witnessed the passage of the Medicare Modernization Act, which legislated the US government into the role of the largest payor for drugs and devices.
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