Pharmacovigilance Project Manager
Location: United States
Requisition Number: 6084
Position Title: Pharmacovigilance Project Manager
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Summary: Responsible for managing key client relationships and overseeing a program of studies for a specific client, providing pharmacovigilance leadership, management and expertise to staff working on projects within the program. Focus on providing proactive management across a portfolio of studies to ensure continuity and consistency in communication and case processing.
Tasks may include but are not limited to:
- Serve as primary point of contact with client as well as internal team to ensure consistency, compliance and quality across projects
- Oversee the management, monitoring, adjustment and ongoing revision of safety management plans (updates to plans, review of risks and identification of new mitigation strategies)
- Provide periodic management level QC of cases to ensure consistency, quality and compliance in case processing
- Maintain and QC PV section of TMF
- Track and monitor PV status for each project
- Generate and provide status reports including line listings and metrics to monitor compliance, progress and quality
- Manage deliverables across the PV team
- Manage change orders and out of scopes
- Monitor progress and provide oversight and alignment across PV team for consistency, compliance, quality
- Represent PV at key client meetings
- Responsible for liaising and collaborating with other Worldwide Clinical Trials departments working with the same client.
- May serve in a line manager capacity with direct reports depending on business needs
- Provide direct supervision of assigned staff and projects including ensuring:
- All pharmacovigilance activities are performed according to applicable regulations and processes
- Work is performed according to the budgeted scope of work
- Work is performed within applicable timelines and according to applicable quality standards
- Provide guidance and coaching to direct reports
- Provide direct supervision of assigned staff and projects including ensuring:
- Escalate any issues or concerns related to study or staff conduct
- Maintain knowledge and understanding of safety related regulations and guidelines
- Maintain basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope
- May participate in proposal review and budget process, bid defence meetings, authoring department standard operating procedures
- Organize and provide training sessions
- Participate in staff recruitment and on-boarding
- May represent PV at sponsor audits as needed
- Participate in department and company-wide initiatives as needed
- May serve as back-up to senior PV leadership as needed
- Perform other duties as assigned.
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Other Skills and Abilities:
- Excellent understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements.
- Excellent understanding of computer technology, and management of relational database systems, including extraction of data.
- Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment.
- Excellent organization skills and ability to handle multiple competing priorities within tight timelines
- Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilities.
- Ability to anticipate needs and follow through on all assigned tasks
- Able to effectively receive and provide constructive feedback without becoming defensive.
- Able to work well independently, but also able to seek input effectively from others when appropriate. Makes sound decisions within the scope of responsibility. Focuses on solutions and problem resolution verses complaining or placing blame.
- Bachelor’s degree in a science-related field, or nursing, or equivalent.
- Minimum of 5 years of global pharmacovigilance experience (pre-approval clinical trials) across a variety of phases and therapeutic areas
- Demonstrated history of strong leadership skills including a minimum of 2 years in a mentorship capacity.
- Equivalent combination of relevant education and experience.
- Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word).
- Excellent written and verbal communication skills
- Excellent organization skills and attention to detail
- Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines.
- Ability to work independently, prioritize work effectively and work successfully in matrix team environment
- Proven experience in clinical trials with a strong knowledge of SOPs, regulatory reporting requirements and accepted practices
- Good understanding of the work performed by other functions and how they interact
- Understanding of and appreciation of the wider issues affecting the efficiency and running of the department
- Proven ability for working independently with minimal supervision
- Proven experience of good interpersonal and communication skills when dealing with Sponsors, supporting colleagues and making presentations
- Confidence in dealing with external and internal clients and providers
- Ability to motivate other team members to achieve project and personal targets
- Proven ability to guide and supervise less experienced staff
- Ability and willingness to travel domestically and internationally if needed to support project meetings, bid defences and/or provide support for business development efforts
- Fluent in written and verbal English
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
The company reserves the right to amend this job description in consultation with the employee to reflect changes in its organizational structure or to the job itself in line with emerging business needs
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
Employment Type: Regular
Community / Marketing Title: Pharmacovigilance Project Manager
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.