Pharmacovigilance Project Manager
- Experience Level
- Experienced (non-manager)
Lead UBC pharmacovigilance project teams to deliver project milestones and oversee all aspects of the safety project conduct from start-up through close-out.
- Bachelor, MSc or equivalent
- 2 year 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
- 10% travel
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
United BioSource Corporation (UBC) 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.
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