Pharmacovigilance Systems Administrator

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!

*SUMMARY: Responsible for the coordination, management, and operation of the Pharmacovigilance (PV) Safety Systems in accordance with applicable regulatory guidelines/requirements, Worldwide Operating Procedures (SOPs) and project specific instructions.*

RESPONSIBILITIES:

Tasks may include but are not limited to:

Provide set up, management and maintenance of the Worldwide pharmacovigilance systems ensuring:

All pharmacovigilance safety database and systems activities are performed according to applicable SOPs, processes, and regulations.
Work is performed within applicable timelines and according to applicable quality standards.
Work is performed within the budgeted scope of work.

Support the day to day functions of Pharmacovigilance systems.
Troubleshoot complex problems involving pharmacovigilance systems.
Maintain an understanding and provide oversight of pharmacovigilance systems at a cross regional level.
Provide guidance and coaching on daily use of the pharmacovigilance systems.
Maintain knowledge and understanding of safety related regulations and guidelines.
Escalate any issues or concerns related to systems.
May participate in reviewing department standard operating procedures.
Organize and provide training sessions.
Participate in staff on-boarding regarding Pharmacovigilance systems.
May provide PV support to management at sponsor audits as needed.
Provide consultation to PV management for clients or potential clients on complex pharmacovigilance data transfers.
Participate in department and company-wide initiatives as needed.
Perform other duties as needed.

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 organization skills and ability to handle multiple competing priorities within tight timelines.
Excellent understanding of computer technology, and management of relational database systems, including extraction of data.
Good knowledge of medical terminology.
Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment.
Consistently demonstrates commitment, dependability, cooperation, adaptability, and flexibility in executing daily tasks and responsibilities.
Ability to anticipate the 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.
Able to make sound decisions within the scope of responsibility and focus on solutions and problem resolution verses complaining or placing blame.
Handle confidential and sensitive matters with discretion.

REQUIREMENTS:

3-5 years of related pharmacovigilance systems experience.
Advanced understanding of pharmacovigilance systems, safety databases in particular.
Excellent written and verbal communication skills
Excellent organization skills and attention to detail.
Demonstrated ability to handle multiple competing priorities with adhering to applicable timelines.
Ability to work independently, prioritize work effectively and work successfully in matrix team environment.
Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word).
Good understanding of the work performed by PV staff.
Understanding of and appreciation of the wider issues affecting the efficiency and running of the department.
Proven ability to work independently with minimal supervision.
Proven experience of good interpersonal and communication skills when dealing with supporting colleagues, and making presentations.
Confidence in dealing with external and internal clients and providers.
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.

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 www.Worldwide.com 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're on a mission to hire the very best and 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