Drug Safety Specialist

Job DescriptionJob Description

DRUG SAFETY SPECIALIST

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity.We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any can look forward from day one to the future theyve envisioned.

POSITION SUMMARY:

The Drug Safety Specialist is primarily responsible for case processing of serious adverse events, serious and non-serious adverse drug reactions and other medically related project information such as adverse events of special interest and product complaints.

This position has the potential to be fully remote. Occasional travel will be required for in person meetings.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Reviews, processes, and assesses adverse event reports (AERs) from clinical trials and post-marketing sources
• Enters and maintains safety data in the global safety database
• Prepares and submits safety reports to regulatory authorities in accordance with global safety reporting requirements
• Performs QC of cases to ensure quality levels are maintained per DOBs expectations
• Manages the safety intake mailbox including the triage of incoming reports for completeness, legibility, and validity
• Query management
• Maintains electronic documentation for case files within the safety database
• Assists with reconciliation of the safety and clinical trial databases
• Collaborates with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory agencies
• Adheres to all relevant pharmacovigilance regulations and company policies
• Assists in development of project-specific safety procedures, workflows, and templates.
• Assists in project-specific safety database setup, management of data entry guidelines, and user acceptance testing.
• MedDRA and WHODrug coding in the safety database
• Preparation for, participation in, and follow-up on audits and inspections
• Provides training and guidance to colleagues on drug safety processes and procedures.
• Stays updated on industry developments and changes in drug safety regulations.
• Maintains confidentiality and adheres to ethical standards in handling sensitive and confidential information.
• Performs other duties and responsibilities as assigned by management

QUALIFICATIONS

• Degree in Pharmacy, Nursing, Life Science, or other fields, or equivalent qualification/work experience
• The ideal candidate will have 2+ years of recent case processing experience and must include experience processing post-marketing cases
• MedDRA and WHODrug coding experience
• Must be fluent in English with excellent written and verbal communication skills
• Detail orientated and capable of working effectively within a team environment.
• Excellent organizational and prioritization skills
• Analytical and problem-solving skills
• Able to perform database/literature searches
• Experience working in RxLogixs Pharmacovigilance Case Management system a plus

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

INTERVIEW INTEGRITY

At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone.

COMPENSATION AND BENEFITS

The salary range for this position is $100,000 - $120,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

Please visit

DISCLAIMER

Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to , , , , (including childbirth and related medical conditions), , , physical and mental , marital status, , , expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date.  Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a and/or a sincerely held belief.

We are unable to sponsor or take over sponsorship of any applicant work visas at this time.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceuticals internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.