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: Email - PAY RANGE AND BENEFITS: Pay Range : $80-$85/hr Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). About Innova Solutions: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: Named One of America's Best Employers for New Grads by Forbes (2024 Named One of the Best Companies to Work for by U.S. News & World Report (Private Companies List, ) One of the Largest IT Staffing Firms in the US - Ranked by Staffing Industry Analysts (SIA, 2024) One of the Largest Staffing Firms in the US - Ranked by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics) Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023) One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024) AWS Advanced Tier Services Partner with 100+ certifications Website: Innova Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at and earn $250-$1,000 per referral. Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or . Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
