What are the responsibilities and job description for the Senior Drug Safety Associate, Pharmacovigilance - US - Remote at Worldwide Clinical Trials Holdings, Inc. position at Direct-Calls.com?
Job Description
Job Summary Senior Drug Safety, Pharmacovigilance – responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines, company SOPs and project instructions. Serves independently as Lead PV Associate on large studies or programs that are moderate to complex. Provides mentorship and leadership with minimal supervision. Key Responsibilities Author Safety Management Plan for assigned studies Review incoming SAE data for completeness and accuracy Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information Generate queries for missing or unclear information and follow-up with sites for resolution Perform QA/QC of SAEs processed by other PV Associates Generate regulatory reports and perform safety submissions as needed Qualifications and Experience Bachelor's degree in a science‑related field, nursing, or equivalent Minimum 5 years of pharmacovigilance experience in pre‑approval clinical trials Excellent understanding of medical and scientific terminology, principles of clinical assessment of adverse drug events, international regulations and reporting requirements Strong computer skills and management of relational database systems, including data extraction MS Office proficiency (Excel, PowerPoint, Word) Excellent written and verbal communication skills, attention to detail, and organizational skills Ability to handle multiple competing priorities while adhering to timelines and to work independently in a matrixed team environment Willingness to travel domestically and internationally as needed (e.g., Investigator meetings, project kick‑off, bid defense) Fluent in written and verbal English EEO Statement 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. #J-18808-Ljbffr Worldwide Clinical Trials Holdings, Inc.
Job Tags
Remote job, Worldwide
Job Summary Senior Drug Safety, Pharmacovigilance – responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines, company SOPs and project instructions. Serves independently as Lead PV Associate on large studies or programs that are moderate to complex. Provides mentorship and leadership with minimal supervision. Key Responsibilities Author Safety Management Plan for assigned studies Review incoming SAE data for completeness and accuracy Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information Generate queries for missing or unclear information and follow-up with sites for resolution Perform QA/QC of SAEs processed by other PV Associates Generate regulatory reports and perform safety submissions as needed Qualifications and Experience Bachelor's degree in a science‑related field, nursing, or equivalent Minimum 5 years of pharmacovigilance experience in pre‑approval clinical trials Excellent understanding of medical and scientific terminology, principles of clinical assessment of adverse drug events, international regulations and reporting requirements Strong computer skills and management of relational database systems, including data extraction MS Office proficiency (Excel, PowerPoint, Word) Excellent written and verbal communication skills, attention to detail, and organizational skills Ability to handle multiple competing priorities while adhering to timelines and to work independently in a matrixed team environment Willingness to travel domestically and internationally as needed (e.g., Investigator meetings, project kick‑off, bid defense) Fluent in written and verbal English EEO Statement 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. #J-18808-Ljbffr Worldwide Clinical Trials Holdings, Inc.
Job Tags
Remote job, Worldwide