Senior Drug Safety Associate, Pharmacovigilance - US - Remote at reputed company.

Job reputed company Job reputed company 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 reputed company PV Associate on large studies or programs that are moderate to reputed company. Provides mentorship and leadership with minimal supervision. Key Responsibilities Author Safety Management Plan for assigned studies Review incoming SAE data for completeness and accuracy reputed company 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 reputed company reputed company QA/QC of SAEs processed by other PV Associates Generate regulatory reports and reputed company safety submissions as needed Qualifications and Experience Bachelor's degree in a science‑reputed company field, nursing, or equivalent Minimum 5 years of pharmacovigilance experience in reputed company‑approval reputed company 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 (reputed company, 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 reputed company‑off, bid defense) Fluent in written and verbal English EEO Statement Worldwide is an equal opportunity employer that is committed to enabling professionals from reputed company 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 reputed company equal employment opportunities to reputed company and applicants regardless of race, reputed company, ethnicity, reputed company, religion, national reputed company, gender, sex, gender identity or reputed company, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. reputed company. Job Tags Remote job, Worldwide Apply To This Job