Job Description
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 3,500+ 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.
Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!
What Pharmacovigilance department does at Worldwide Pharmacovigilance is the gateway to ensuring drug safety! Our Pharmacovigilance team comprises a dynamic group of individuals with extensive experience within the Drug Safety world. Watching drugs progress from First in Human Administration to global regulatory approval, we can be a part of the entire lifecycle of a compound making it to the market. We review safety events from all over the world and work with our clients to review, analyze, and submit to Investigators, Ethics Committees/IRBs, and Regulatory Agencies furthering clinical drug development!
What you will do - Provide direct supervision of assigned staff and projects including ensuring all pharmacovigilance activities are performed according to applicable regulations and processes
- Provide guidance and coaching to direct reports
- 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
What you will bring to the role - 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
Your experience - Bachelor’s degree in a science-related field, or nursing, or equivalent
- Minimum of 5 years of pharmacovigilance experience (pre-approval clinical trials)
- Equivalent combination of relevant education and experience.
- Ability to motivate other team members to achieve project and personal targets
- Proven ability to guide and supervise less experienced staff
- Confidence in dealing with external and internal clients and providers
- Excellent written and verbal communication skills
- Good understanding of the work performed by other functions and how they interact
- Fluent in written and verbal English
- Ability and willingness to travel domestically and internationally if needed to support project meetings, bid defences and/or provide support for business development efforts
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide !For more information on Worldwide, visit or connect with us on LinkedIn .
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 know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. 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
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Job Tags
Permanent employment, Worldwide,