Innova Solutions has a client that is immediately hiring a Global Safety Scientist. Position type : Full Time - Contract Duration : 6 Months Location : Remote As a Global Safety Scientist, you will : Description The ideal candidate will have a minimum bachelor’s degree with 4+ years (or master’s with 2+ years) of direct pharmacovigilance experience, including safety signal assessment and working with safety documentation such as periodic reports. A healthcare / science background (such as pharmacy, nursing, biology, or microbiology is strongly preferred), with added value for oncology or immune-oncology product experience. Candidates must demonstrate strong clinical or medical research knowledge related to drug interactions and toxicity. Must be able to attend key meetings on Pacific Time with occasional early / late calls. Responsibilities Contributes to the planning, preparation, writing and review of periodic aggregate safety reports. Works with affiliates and other internal Client partners regarding deliverables. Review of adverse events and serious adverse events from clinical trials. Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents Review standard design of tables, figures, and listings for safety data from clinical studies Participate in development of safety-related data collection forms for clinical studies Attend study team meetings as requested or needed Conduct signal detection, evaluation, and management Perform 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 Client 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 oversee risk minimization activities including tracking of activities as needed Evaluate risk minimization activity Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO Support activities related to new drug applications and other regulatory filings Assist GSO / or other Senior Scientist in developing a strategy for safety-related regulatory activities Provide safety contents for filings Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by the supervisor 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 : Healthcare 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 : source document review, knowledge, and skills Experience with the Argus Safety database Good clinical and scientific judgment Clinical and / or medical research experience Basic Qualifications 0+ Years w / Relevant PhD or equivalent (where applicable) 2+ Years w / Relevant MS or equivalent 4+ Years w / Relevant BS or equivalent Advanced and proficient understanding and use of technical principles, theories, and concepts to perform expansive range of work in a role. Basic knowledge of related and adjacent disciplinary areas. Top 3 Must Have Skill Sets : Healthcare professional background 1 year of drug safety / PV experience Experience in signal detection, evaluation and management Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you! Pradip Joshi Phone : 213-401-2633 Email - Pradip.Joshi@innovasolutions.com PAY RANGE AND BENEFITS : Pay Range
Scientist Scientist Global • Thousand Oaks, CA, United States