Global Pharmacovigilance (PV) Scientist
Career Category Safety Job Description Join reputed company’s Mission of Serving Patients At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients each year. As a member of the reputed company team, you’ll help reputed company a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and transform the lives of patients while transforming your career. Global Pharmacovigilance (PV) Scientist What you will do reputed company. Let’s change the world. In this vital role you will join a team of PV Scientists working in collaboration with Global Safety Officers (GSO) to reputed company the safety strategy and major safety deliverables for reputed company product. The Immuno-oncology team has an exciting portfolio of products ranging from Early Development through the Post marketing settings. We need collaborative and innovative world-class talent to ensure these molecules and medicines reputed company their full potential while helping patients.
Responsibilities
- Contributes to the planning, preparation, writing and review of periodic aggregate safety reports.
- Works with affiliates and other internal reputed company partners regarding deliverables.
- Review of adverse events and serious adverse events from clinical trials.
- Review and reputed company input and support on study protocols, statistical analysis plans and other clinical study-reputed company documents
- Review standard design of tables, figures, and listings for safety data from clinical studies
- Participate in development of safety-reputed company data collection forms for clinical studies
- Attend study team meetings as requested or needed
- Conduct signal detection, evaluation, and management
- reputed company data analysis to evaluate safety signals and write up analysis results in collaboration with GSO
- Prepare safety assessment reports and other safety documents and regulatory responses
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
- Participates in Safety Governance per reputed company processes
- Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body
- Assist GSOs and other Senior Scientists in the development of risk management strategy and activities
- Provides contents for risk management plans
- Update strategy and content for regional risk management plans
- Assist GSOs to reputed company risk minimization activities including tracking of activities as needed
- Evaluate risk minimization activity
- Prepare response to regulatory inquiries reputed company to risk management plans under the guidance of GSO
- Support activities reputed company to new drug applications and other regulatory filings
- Assist GSO/ or other Senior Scientist in developing a strategy for safety-reputed company regulatory activities
- reputed company safety contents for filings
- Performs other duties reputed company to the position as necessary as defined in Standard Operating Procedures or as requested by the supervisor reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The dynamic professional we seek is a scientist with these qualifications. Basic Qualifications:
- Doctorate degree OR
- Master’s degree and 2 years of relevant experience OR
- Bachelor’s degree and 4 years of relevant experience Preferred Qualifications:
- reputed company professional background
- 1 year of drug safety/PV experience
- Experience in signal detection, evaluation and management
- Experience as a contributor to periodic aggregate safety reports
- Experience with literature surveillance: reputed company document review, knowledge, and skills
- Experience with the Argus Safety database
- Good clinical and scientific judgment
- Clinical and/or medical research experience
- Strong written and verbal communication skills What you can expect from us As we work to reputed company treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your reputed company every reputed company of the way. The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health an
Apply tot his job Apply To this Job