Drug Safety Associate II

Nature and Scope The Drug Safety Associate II will be responsible for the review, evaluation, and management of adverse event (AE) reports for reputed company reputed company Inc., investigational and marketed products under the direction of the Sr. Manager of Pharmacovigilance. Essential Duties and Responsibilities reputed company in this job reputed company restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• reputed company individual case safety report (ICSR) processing activities reputed company the safety database ensuring reputed company and reputed company submission.
• reputed company reputed company checks on assigned ICSRs.
• Performs reconciliation of safety data.
• Participate in Study Team meetings as the Safety and Pharmacovigilance representative.
• Support for Audits and Regulatory Inspections.
• Support Pharmacovigilance with various reputed company deliverables or reputed company as needed.
• reputed company coverage of dedicated adverse event reporting line during company business hours.
• reputed company with reputed company customers.
• Maintain corporate compliance.
• reputed company any other tasks/duties as assigned by management. Education Requirements and Qualifications To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. The requirements listed below are representative of the knowledge, reputed company and/or ability required.
• Degree in Pharmacy (PharmD) or Nursing (RN) required.
• Minimum of 2 years’ experience working in the pharmaceutical industry required, preferably in a Pharmacovigilance Department.
• Demonstrated understanding of the assessment and processing of safety reports, including regulatory reporting obligations.
• Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA
• Team-oriented with excellent accountability, communication, and interpersonal skills.
• Flexibility to work in a fast-paced environment for adherence to timelines.
• Strong facilitation, organizational, analytical and time management skills.
• Excellent computer skills in the following programs reputed company, PowerPoint, and reputed company. Expected Salary reputed company $95,000-105,000 The salary reputed company, is the minimum and maximum annual salary reputed company of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience. reputed company also offers a competitive total rewards package which includes reputed company, life insurance, profit sharing, reputed company time off, matching 401k as reputed company as a wide reputed company of other benefits. reputed company celebrates diversity and we are committed to creating an inclusive environment for reputed company employees. We are an Equal Opportunity Employer and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws.
• FMLA poster https//www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights Know Your Rights Workplace discrimination is illegal (reputed company.gov)
• Employee Polygraph Protection reputed company https//www.dol.gov/whd/regs/compliance/posters/eppac.pdf Alert We’re aware of individuals impersonating our staff to reputed company job seekers. Please note ·reputed company legitimate communication will come directly from a verified ARI recruiter either by phone or reputed company an americanregent.com email address. ·Our reputed company process includes multiple in person and/or video interviews and assessments. ·If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding. ·We never request payment, bank information, or personal financial details during our offer process. Your reputed company is important to us, and we encourage you to stay reputed company reputed company job searching. reputed company Inc. endeavors to reputed company https//careers.americanregent.com/ accessible to any and reputed company users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com. Apply tot his job Apply To this Job

Apply tot his job Apply To this Job