What are the responsibilities and job description for the Drug Safety Associate II, Pharmacovigilance - US - Remote position at Worldwide Clinical Trials - USA?
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: Collection, processing and evaluation of the information on Serious Adverse Events (SAEs) that are reported to the Company, including preparation of summary narratives of the information contained in the case, assigning the proper regulatory reporting status, and accurately entering the data into Drug Safety Database.* *Assist the Drug Safety Manager/Officer in the preparation of periodic safety reports to be submitted to regulatory authorities worldwide and provide routine database searching, extraction and reporting services to the department.* *RESPONSIBILITIES:* _Tasks may include but are not limited to:_ Evaluation of case information, determination of the regulatory reporting status of each case and accurate entry of case information into the safety database. Provide retrieval and reporting of data from the WCT’s global safety database. Ad hoc data extraction and reporting as requested by internal and external customers. Support to the Safety Officer in the generation of Safety Update Reports (ASR, Periodic Line listings) and other regulatory reports. Interaction with other functions (ClinOps, Data Mangement), including database reconciliation. Assures that all safety data originated in projects assigned are handled in accordance with WCT global standard operative procedures and local working practices. Act as a support person in the preparation of study-specific Safety Monitoring Plans in order to gain a deep knowledge of how to handle the SAE cases in the specific study. Contribute in the safety signal generation and evaluation process through safety database searching and extracting. Be always updated on the laws/guidelines/regulations of drug safety in the region. 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: * Good understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements. Good understanding of computer technology, and management of relational database systems, including extraction of data. Good oral and written communication skills. High skills in time management and organization. Fluency in written and verbal English *REQUIREMENTS:* Bachelor degree in a science-related field, or nursing, or equivalent. 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’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.
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: Collection, processing and evaluation of the information on Serious Adverse Events (SAEs) that are reported to the Company, including preparation of summary narratives of the information contained in the case, assigning the proper regulatory reporting status, and accurately entering the data into Drug Safety Database.* *Assist the Drug Safety Manager/Officer in the preparation of periodic safety reports to be submitted to regulatory authorities worldwide and provide routine database searching, extraction and reporting services to the department.* *RESPONSIBILITIES:* _Tasks may include but are not limited to:_ Evaluation of case information, determination of the regulatory reporting status of each case and accurate entry of case information into the safety database. Provide retrieval and reporting of data from the WCT’s global safety database. Ad hoc data extraction and reporting as requested by internal and external customers. Support to the Safety Officer in the generation of Safety Update Reports (ASR, Periodic Line listings) and other regulatory reports. Interaction with other functions (ClinOps, Data Mangement), including database reconciliation. Assures that all safety data originated in projects assigned are handled in accordance with WCT global standard operative procedures and local working practices. Act as a support person in the preparation of study-specific Safety Monitoring Plans in order to gain a deep knowledge of how to handle the SAE cases in the specific study. Contribute in the safety signal generation and evaluation process through safety database searching and extracting. Be always updated on the laws/guidelines/regulations of drug safety in the region. 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: * Good understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements. Good understanding of computer technology, and management of relational database systems, including extraction of data. Good oral and written communication skills. High skills in time management and organization. Fluency in written and verbal English *REQUIREMENTS:* Bachelor degree in a science-related field, or nursing, or equivalent. 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’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.
