Project Director, Pharmacovigilance
- Experience Level
- Experienced (non-manager)
**If applicant is not local to Blue Bell, Pennsylvania (headquarters), travel to headquarters may be required on a quarterly basis to meet with team and leadership.**
Responsible for directing pharmacovigilance (PV) staff who perform project management for all PV projects contracted by UBC clients. Leads UBC PV project teams to deliver contracted services and ensuring achievement of contracted project milestones for assigned projects. Responsible for the management and oversight of PV vendors contracted by UBC.
- Bachelor’s degree or equivalent experience.
- Minimum 10 year direct project management experience at a Contract Research Organization (CRO) or pharmaceutical company and 6 years of pharmacovigilance experience managing multiple projects and project teams on a global basis including management responsibilities at the department level.
- Strong knowledge of global and local PV regulations and legislation, both pre- and post-marketing.
- Strong project management, interpersonal, verbal and written communication skills, both internally and towards clients.
- Experience with Argus or other industry standard safety database(s)
- Project financial expertise including invoicing, revenue recognition, margin analysis, scope management and resource management.
- Demonstrated supervisory skills preferred.
- Demonstrated independent problem solving and issue resolution track record.
- Excellent interpersonal and client management skills.
- Effective presentation skills.
- Must be flexible and adaptable to quickly changing project priorities
- Must be able to speak fluent English.
- Ability to travel to UBC locations, clients, and professional/scientific meetings.
- Responsible for the supervision of global Project Management staff (direct reports and indirect direct reports including Associate Project Directors, Senior Project Managers and Project Managers, Pharmacovigilance).
- Matrix supervision of project team(s).
Specific Job Duties:
- Manages Pharmacovigilance project(s) as assigned by UBC PV Management per the scope of work and within the contracted budget and timelines.
- Direct supervision of Associate Project Directors and Project Managers, Pharmacovigilance, including development of Associate Project Directors and Project Managers in presentation and bid defense of proposals, proposal and implementation of action plans, preparation of GAANT charts and ensuring Associate Project Director and Project Manager has a clear understanding of clients needs once a project is awarded.
- Provide back up support to the Associate Project Directors when they’re out of the office.
- Ensure performance of project deliverables according to contract terms and UBC quality expectations, including accurate reporting and interpretation of metrics.
- Responsible for the selection, qualification and monitoring of the performance of the UBC PV vendors.
- Plan, develop and maintain UBC sponsor specific policies, procedures, operational plans, SOPs, systems, forms, reports and vendor/sub-contactor relationships according to sponsor guidelines and standards.
- Develop internal standard for the Project Management activities within global Pharmacovigilance, including internal SOPs, guidelines, metrics and standards.
- Work closely with Pharmacovigilance leadership on a global basis to ensure optimal project organization and resourcing.
- Proactively serve as a resource and line of escalation to Associate Project Directors and (Sr)Project Managers and teams for problem resolution; facilitate the involvement of additional UBC senior management as necessary.
- Participate in client meetings, calls and project specific activities as appropriate to ensure Project Managers are meeting client’s needs in a systematic manner
- Responsible for the selection, training, development plans, and yearly appraisals of employees directly under his/her supervision.
- Work with UBC’s Business Development to develop and grow UBC client relationship and business to maximum potential.
- Evaluates and responds to client requests for proposals, including writing text when appropriate. Participates in bid defense preparation and attendance. Ensures project management aspects of the project following proposal acceptance.
- Participates in monthly PV Leadership meetings.
- Leads and attends client audits and regulatory inspections.
- Participates in PV budget planning including resource allocation and training needs.
UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.
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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