Job Description
Pay range: 68-78/hr
*depending on experience
The ideal candidate will have a minimum bachelors degree with 4+ years (or masters 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, be proactive, self-sufficient, adaptable, and collaborative. 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 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 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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a scientist with these qualifications.
Basic Qualifications:
Doctorate degree OR
Masters degree and 2 years of relevant experience OR
Bachelors 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
Strong written and verbal communication skills
Job Tags
Remote job, Contract work,