Planet Pharma
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Senior PV Scientist
role at
Planet Pharma
Pay is commiserate with experience and ranges between $50-70/hr.
Duties And Responsibilities
Serve as key analytic and safety support lead in close collaboration with the product safety physician for the assigned product(s)
Responsible to analyze potential safety issues, including signal detection, signal evaluation and signal management. This includes coordination and documentation of all signal review activities.
Contribute to signaling and data mining activities utilizing internal and external sources of data
Coordinate with Safety physician to lead Safety Committee meeting preparation and documenting of meeting minutes
Performing sponsor review of serious adverse events outsourced to our PV vendor
Responsible for safety review of protocol and CRFs, safety content of IB, ICF, and other documents to appropriately support Clinical study activities.
Lead and author aggregate safety reports (e.g., DSUR/PSUR/PADER) in collaboration with key stakeholders and vendor.
Coordinate ad hoc safety query or health hazard evaluation response plan for analysis in conjunction with the safety physician, Biostatistics and others as needed, including performing analysis and drafting of query responses for review and finalization.
Key safety representation in Integrated Safety Summary reviews, Clinical study reports which may include narrative generation, review and approval for filing related activities.
Keeping updated on relevant regulations associated with the above activities. Contributes to initiatives for process improvement and cross-product process consistency.
Other tasks as assigned or required
Qualifications
Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist or similar role.
Demonstrated experience in analyzes, and interpretation of medical and scientific data and excellent verbal and written skills.
Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Biostatistics, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
Strong organizational, project management and leadership skills: Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
Applies clinical judgment to interpret case information.
Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.
Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects) and Argus Safety systems
Education
Advanced degree (PharmD, RN, MD, PhD, MPH, NP)
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Senior PV Scientist
role at
Planet Pharma
Pay is commiserate with experience and ranges between $50-70/hr.
Duties And Responsibilities
Serve as key analytic and safety support lead in close collaboration with the product safety physician for the assigned product(s)
Responsible to analyze potential safety issues, including signal detection, signal evaluation and signal management. This includes coordination and documentation of all signal review activities.
Contribute to signaling and data mining activities utilizing internal and external sources of data
Coordinate with Safety physician to lead Safety Committee meeting preparation and documenting of meeting minutes
Performing sponsor review of serious adverse events outsourced to our PV vendor
Responsible for safety review of protocol and CRFs, safety content of IB, ICF, and other documents to appropriately support Clinical study activities.
Lead and author aggregate safety reports (e.g., DSUR/PSUR/PADER) in collaboration with key stakeholders and vendor.
Coordinate ad hoc safety query or health hazard evaluation response plan for analysis in conjunction with the safety physician, Biostatistics and others as needed, including performing analysis and drafting of query responses for review and finalization.
Key safety representation in Integrated Safety Summary reviews, Clinical study reports which may include narrative generation, review and approval for filing related activities.
Keeping updated on relevant regulations associated with the above activities. Contributes to initiatives for process improvement and cross-product process consistency.
Other tasks as assigned or required
Qualifications
Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist or similar role.
Demonstrated experience in analyzes, and interpretation of medical and scientific data and excellent verbal and written skills.
Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Biostatistics, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
Strong organizational, project management and leadership skills: Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
Applies clinical judgment to interpret case information.
Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.
Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects) and Argus Safety systems
Education
Advanced degree (PharmD, RN, MD, PhD, MPH, NP)
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr