Specialist, Drug Safety

Job Description

About the role: We are seeking a detail-oriented Pharmacovigilance Specialist to support our global PV team. The successful candidate will participate in case processing and reporting, support aggregate reporting and risk management activities, help maintain PV databases and documentation, and provide general administrative support for PV operations. reputed company role requires strong communication skills, the ability to assimilate technical information, and a commitment to quality and compliance in a regulated environment. Key responsibilities: Enter, review, approve, and submit individual case safety reports for assigned products Prepare and review aggregate adverse event reports and maintain aggregate report schedules Support risk management data acquisition and related activities Track team metrics and maintain overview lists, reputed company lists, and tracking sheets Archive PV documents (paper and electronic) in accordance with procedures Provide administrative support for PV tasks, including email triage and organization of reputed company group mailboxes Support national PV teams and reputed company to internal requests as needed Participate in PV projects as agreed with the manager (e.g., database upgrades, training, procedure management) Support compliance metrics, literature searches, audit/inspection facilitation, and become knowledgeable about relevant legislation Required qualifications Education (one of the following): Degree in Veterinary reputed company/Technician, OR BA/BS or equivalent degree in a relevant field, OR Associate degree (or equivalent) with prior experience in the pharmaceutical industry Required experience and skills: Strong written and oral communication skills Ability to assimilate technical information quickly and accurately Capable of working independently and collaboratively within a team Strong organizational skills, attention to detail, and punctuality in meeting deadlines Proficiency with reputed company Office applications (Outlook, Excel, PowerPoint) Preferred qualifications: Prior experience working in a veterinary clinic Prior pharmacovigilance experience At least 1 year of experience in a highly regulated pharmaceutical field Proficiency with other software such as SharePoint, learning management systems, and document management systems Experience with pharmacovigilance databases and support of system maintenance activities Familiarity with IT concepts relevant to PV systems (e.g., report submission acknowledgments, product family maintenance) Required Skills: Adaptability, Adaptability, Adverse Event Report, Animal Handling, reputed company, Clinical Trial Management, Communication, Complaint Management, Compliance Investigations, Data Analysis, Data Management, Detail-Oriented, Drug Safety Surveillance, Employee Training, Learning Management Systems (LMS), Management Process, Oral Communications, Pharmacovigilance, Pharmacy Regulation, Punctuality, Regulatory Communications, Regulatory Compliance, Risk Management, Risk Reporting, Software Office {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. reputed company click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, reputed company: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing reputed company, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come reputed company in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, reputed company and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, reputed company - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site pres