Planet Pharma
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http://www.theplanetgroup.com
http://www.theplanetgroup.com
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Drug Safety Specialist
11388 Sorrento Valley Road San Diego, CA 92121 US
Posted: 05/19/2023
2023-05-19
2023-07-03
Employment Type:
Contract
Job Category: Pharmacovigilance
Job Number: 566339
Is job remote?: Yes
Country: United States
Job Description
POSITION SUMMARY:
Pay rate range: $50-55/hr
The Drug Safety Specialist supports a number of post-marketing and/or clinical safety activities, including, but not limited to, the handling of cases received from clinical trials, collaborating partners and/or identified in articles/abstracts, ensuring the uniform and timely intake, processing, and submission to regulatory agencies of individual case safety reports, if applicable. They ensure compliance with global regulations and Halozyme standard operating procedures. They review clinical trial and post-marketing safety information; and assist in the preparation of periodic safety reports, and other documents, as needed.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include, but are not limited to:
• Ensure that clinical and/or post marketing adverse event reports are received, tracked, evaluated including the initial assessment of seriousness, listedness/expectedness, and causality. Ensure cases are processed/imported into the Argus safety database (including the authoring of narratives/queries/QC), and distributed in an efficient and timely manner and in compliance with regulations and Halozyme SOPs
• Perform E2B importing and monitoring in Argus safety database. Ensure timely and clear communication with partners for importing/transmitting issues.
• Review literature articles and abstracts to identify ICSRs and extract the proper information for safety data processing including adverse events, procedures and suspect products.
• Perform data entry of post-marketing and clinical ICSRs into the safety database.
• Complete adverse event reconciliation for ICSRs received from partners.
• Maintain ICSR case files and related safety documentation.
• Manage the drug safety mailbox.
• Identify and respond appropriately to new safety reports to protect patients and maintain full compliance with regulatory requirements.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
• Bachelor’s degree in a life science required with at least 2 years drug safety experience.
• Excellent knowledge of FDA safety reporting requirements
• Knowledge of combination product reporting requirements preferred.
• Experience with Argus and workflows
• Experience with SDLC validation
• Experience with the content of pharmacovigilance documents such as SOPs, guidelines, safety plans
• Excellent written, verbal communication, and interpersonal skills
• Critical thinking skills are required.
• Ability to work under pressure and independently.
• Computer/word processing expertise
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A
Software Knowledge: Argus, Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: Oracle Argus – End User-level experience.
INTERNAL AND EXTERNAL RELATIONSHIPS:
• Effectively collaborate with other line functions within Halozyme (e.g., Clinical Regulatory Affairs, Finance, etc.).
• Build positive relationships with external parties, including CROs and study site staff.
• May participate as the clinical safety representative on product development sub-teams.
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 10 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.
TRAVEL:
Travel may be required up to 20% of your time
Pay rate range: $50-55/hr
The Drug Safety Specialist supports a number of post-marketing and/or clinical safety activities, including, but not limited to, the handling of cases received from clinical trials, collaborating partners and/or identified in articles/abstracts, ensuring the uniform and timely intake, processing, and submission to regulatory agencies of individual case safety reports, if applicable. They ensure compliance with global regulations and Halozyme standard operating procedures. They review clinical trial and post-marketing safety information; and assist in the preparation of periodic safety reports, and other documents, as needed.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include, but are not limited to:
• Ensure that clinical and/or post marketing adverse event reports are received, tracked, evaluated including the initial assessment of seriousness, listedness/expectedness, and causality. Ensure cases are processed/imported into the Argus safety database (including the authoring of narratives/queries/QC), and distributed in an efficient and timely manner and in compliance with regulations and Halozyme SOPs
• Perform E2B importing and monitoring in Argus safety database. Ensure timely and clear communication with partners for importing/transmitting issues.
• Review literature articles and abstracts to identify ICSRs and extract the proper information for safety data processing including adverse events, procedures and suspect products.
• Perform data entry of post-marketing and clinical ICSRs into the safety database.
• Complete adverse event reconciliation for ICSRs received from partners.
• Maintain ICSR case files and related safety documentation.
• Manage the drug safety mailbox.
• Identify and respond appropriately to new safety reports to protect patients and maintain full compliance with regulatory requirements.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
• Bachelor’s degree in a life science required with at least 2 years drug safety experience.
• Excellent knowledge of FDA safety reporting requirements
• Knowledge of combination product reporting requirements preferred.
• Experience with Argus and workflows
• Experience with SDLC validation
• Experience with the content of pharmacovigilance documents such as SOPs, guidelines, safety plans
• Excellent written, verbal communication, and interpersonal skills
• Critical thinking skills are required.
• Ability to work under pressure and independently.
• Computer/word processing expertise
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A
Software Knowledge: Argus, Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: Oracle Argus – End User-level experience.
INTERNAL AND EXTERNAL RELATIONSHIPS:
• Effectively collaborate with other line functions within Halozyme (e.g., Clinical Regulatory Affairs, Finance, etc.).
• Build positive relationships with external parties, including CROs and study site staff.
• May participate as the clinical safety representative on product development sub-teams.
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 10 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.
TRAVEL:
Travel may be required up to 20% of your time
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