Pharmacovigilance Solutions Mgr
Manage multiple customer relationships in which customers are provided safety-related services. Oversee all aspects of
Pharmacovigilance (PhV) project/program performance including timeline, quality, and budget for specified customers.
Participate in the development of PhV project management staff. Advise PhV lead staff on project-related issues. Manage
PhV projects with annual project revenue for PhV over $1 million and related contribution to operating income.
- Fully manage a group of assigned customers ensuring customer satisfaction, financial and operational performance,
serving as primary PhV project manager contact to customers.
- Serve as advisor to PhV project leads and Associate Pharmacovigilance Managers.
- Assist PhV leads/Associate Pharmacovigilance Managers with professional development; provide input to performance
appraisals and mentoring of less experienced PhV leads.
- Partner with sales staff, supporting expansion of business with existing and potential customers through customer
interaction and oversight of proposal strategy and development. Provide sales presentations as required.
- Lead contract and budget renegotiation efforts.
- Serve as a project management liaison with other groups within Quintiles. Represent the department on task forces.
- Participate in organizational PhV project management and operations strategy and policy development.
- May serve as a PhV project manager of large, long-term, complex projects.
- Track financial status of assigned projects; assist with clinical safety-related change orders.
- Provide project metrics and status reporting.
- Maintain project quality and perform project specific training.
- Initiate customer feedback and respond to feedback received.
- Audit attendance and development of any CAP in conjunction with Quality Management, as required.
- Assist senior leaders in managing department by identifying, developing and implementing new processes and systems
designed to improve quality and efficiency, updating managers on new regulations, representing department at sales,
marketing, bid defense and other extra-departmental meetings, creating and modifying SOPs and work instructions
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- In-depth knowledge of event processing and clinical event validation and adjudication in both clinical and post marketing
- In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical
Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- In-depth knowledge of departmental standard operating procedures (SOPs)
- Skill in use of multiple safety databases
- Strong project management skills
- Strong coaching skills
- Strong team building skills
- Excellent written communication skills
- Ability to lead projects within strict deadlines
- Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Master’s degree or educational equivalent in a scientific or health care-related discipline and 5 years clinical, research
industry or other relevant work experience including 3 years project lead experience; or equivalent combination of
education, training and experience
EEO Minorities/Females/Protected Veterans/Disabled
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