Planet Pharma ยท 1 day ago
Drug Safety Associate III
Alameda, CA
Full-time
Onsite
Senior Level
$31/hr - $41/hr
5+ years expPlanet Pharma is focused on providing Drug Safety expertise and ensuring the quality documentation of safety data. The Drug Safety Associate III will manage case processing activities in the Argus Safety Database, ensuring compliance with global clinical safety regulations and providing oversight of drug safety study operational activities.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Processing and assessing SAEs from receipt to case closure in the Argus database, including query generation, narrative, and ASE writing
MedDRA coding of SAEs and AEs as reported in source documents of SAE reports and development/revision of MedDRA Coding Conventions to ensure consistent data categorization
Defining and applying a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician
Scheduling submissions of expedited safety reports in ARGUS as needed
Training of new safety staff on Argus and case processing
Collaborating with other departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data
Performing Safety Study Lead activities including:
Review of, Investigator Brochures, study protocols and participation on IND Annual Reports in support of the Drug Safety Physician
Development of study specific safety management plan from Drug Safety template
Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and CRF)
Perform SAE reconciliation, as required by safety management plan
Additional duties and responsibilities as required
Qualification
Required
BS/BA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 7 years of related experience; or
MS/MA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 5 years of related experience; or
PhD in Nursing, Pharmacy, other clinical, or related discipline and 0 or more years of related experience; or
Equivalent combination of education and experience
May require certification in assigned area
Processing and assessing SAEs from receipt to case closure in the Argus database, including query generation, narrative, and ASE writing
MedDRA coding of SAEs and AEs as reported in source documents of SAE reports and development/revision of MedDRA Coding Conventions to ensure consistent data categorization
Defining and applying a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician
Scheduling submissions of expedited safety reports in ARGUS as needed
Training of new safety staff on Argus and case processing
Collaborating with other departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data
Performing Safety Study Lead activities including: Review of, Investigator Brochures, study protocols and participation on IND Annual Reports in support of the Drug Safety Physician
Development of study specific safety management plan from Drug Safety template
Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and CRF)
Perform SAE reconciliation, as required by safety management plan
Knowledge of biotechnology/pharmaceutical sector
Knowledge of regulatory framework governing patient safety
Adopts an analytical approach to solve problems relevant to the role
Demonstrates an understanding of organizational and planning capabilities by managing own time and resources to complete assigned work
Leads self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals
Provides verbal and written communications that are clear and easy to understand. Keeps management informed of potential issues in a timely manner
Works collaboratively with team members
Good interpersonal skills, understanding of differing views and participation in developing agreed upon resolution
Trains on procedures, tasks and tools for role, supported by ongoing coaching and/or mentoring by departmental peers
Develops and maintains knowledge of cross-functional products, tools and data sources
May mentor junior team members
Capable of following predefined procedures for specific tasks
Capable of identifying task-related challenges and prioritizing activity accordingly
Identifies and escalates issues that may have a broader impact
Implements solutions to address any task-related challenges
Preferred
Experience in Biotech/Pharmaceutical industry and/or in oncology preferred
Experience using Argus safety database preferred
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase