A major pharmaceutical company who work to benefit patients wherever they live by uniting worldwide talent and resources with their vision.
KEY SKILLS:
- Pharmacovigilance
- Drug safety
- Phase 1-3 clinical study experience
- Protocol, IB, ICF development
- SMC, DMC
- SAE and aggregate data review and analysis
- Signal detection and signal evaluation
- DSUR authoring
location: Telecommute
job type: Contract
salary: $85 - 100 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
Signal and Safety Data Evaluation
- Lead the identification, analysis, and evaluation of safety signals
- Define data acquisition strategy, methodology, and approach for safety evaluations
- Perform analysis of safety data and lead authoring of safety assessment
- Lead execution of signal assessment strategy and assess potential impact on the product safety profile with recommendation for action and initiate proposal for Safety Management Team
- Lead the preparation and presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)
- Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner.
- Lead the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator's Brochure, Healthcare Professional communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members
- Lead signal assessment documentation following signal management and safety governance framework
- Lead the review of safety data and monitor the safety of patients on allocated clinical trials
- Lead the writing and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, Safety Analysis Plans (SAPs), Tables Figures and Listings (TFLs), Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees
- Support ad-hoc review of the Safety Management Plans
- Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/ Periodic Adverse Experience Report (PAER), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs)
- Lead strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs
qualifications:
- Phase 1-3 clinical study experience
- Protocol, IB, ICF development
- SMC, DMC
- SAE and aggregate data review and analysis
- Signal detection and signal evaluation
- DSUR authoring
PharmD, NP, RN, or PhD in a medical field or biological science and 8+ years of experience as a Safety (Pharmacovigilance) Scientist.
#LI-CV1
skills: Phase I, Phase II, Phase iii, Microbiology, DSUR
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 health, an incentive and recognition program, and 401K contribution (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 in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
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.
