Seeking a Global Safety Scientist with a minimum of 4 years of pharmacovigilance experience, including expertise in safety signal assessment and periodic reporting.
The ideal candidate will have a healthcare or science background and will play a key role in signal detection, risk management, and the preparation of aggregate safety reports. This position requires strong clinical judgment and the ability to collaborate effectively with internal partners and regulatory bodies. Experience in oncology or immuno-oncology is a plus.
Location/Schedule/Shift: 100% remote. Must be able to attend key meetings on Pacific Time with occasional early / late calls.
KEY SKILLS:
- Healthcare professional background
- 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
- Strong written and verbal communication skills
location: Telecommute
job type: Contract
salary: $71.50 - 84.16 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Contributes to the planning, preparation, writing and review of periodic aggregate safety reports.
- Works with affiliates and other internal company 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 company processes
- Prepare presentation of the Global Safety Teams 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
qualifications:
- Doctorate degree (PhD) or Master's degree (MS) and 2 years of years of pharmacovigilance experience, including safety signal assessment and working with safety documentation such as periodic reports OR
- Bachelor's degree (BS) with 4+ years of pharmacovigilance experience, including safety signal assessment and working with safety documentation such as periodic reports OR
- Background in healthcare / science, pharmacy, nursing, biology, or microbiology.
- Strong clinical or medical research knowledge related to drug interactions and toxicity
- 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
- Proactive, self-sufficient, adaptable, and collaborative.
- Strong written and verbal communication skills
- Oncology or immune-oncology product experience preferred.
skills: Adverse Event (AE) Reporting, Signal Detection, Serious Adverse Event (SAE) Reporting, Literature Surveillance and Screening, Drug Drug Interaction Assessment, Risk Assessment and Mitigation
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay 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. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
