Sr. Associate/Manager of Drug Safety and Pharmacovigilance Operations (Contract-to-hire)

At DICE Therapeutics, a wholly-owned subsidiary of Eli Lilly and Company, we design and develop innovative therapies in immunology for patients with debilitating diseases. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.  This is a contract – to – hire opening.

Job Description

The Sr Associate/Manager of DSPV Operations is responsible for supporting Drug Safety activities at DICE, including close collaboration with Eli Lilly, and oversight of CROs/Vendors.

The qualified candidate will perform multiple activities related to overall safety operations, including oversight of case management activities, conduct data review, while ensuring compliance with regulations and company processes.

The successful candidate should have the ability to work in a dynamic, changing environment to meet corporate and patient needs, while ensuring a positive and collaborative team environment.

Roles and Responsibilities

Under the supervision and in collaboration with the Sr. Director of DSPV, this individual will:

• Provide oversight of DSPV vendors, including review/tracking of SAEs/AESI/ICSRs and aggregate report completion/submission/distribution
• Contribute to data review in EDC (AEs, Con Meds, Medical History, Labs)
• Review data collection forms (SAE, eCRFs, Pregnancy, others) and their respective completion guidelines, ICFs, training slides
• Ensure safety data reconciliations occur as agreed with all stakeholders (Eli Lilly, vendors)
• Responsible for ensuring all DSPV documents are appropriately filed within the Trial Master File (TMF)
• Maintain PV inspection readiness, ensuring any Quality Events and CAPAs are properly documented with internal and external stakeholders, in collaboration with the DICE Quality Group.
• Ensure all DSPV trackers are maintained (AE mailbox, Safety Database workflow)
• Ensure cases are cross-reported per agreements (SMP, SDEA)
• Other duties as assigned, on department needs

Qualifications

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, ability to analyze complex issues and escalate to Sr. Management accordingly. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks. Level will be commensurate upon experience and qualifications.

• Bachelor’s degree in life sciences, MD, PhD, PharmD, BSN/RN preferred
• Minimum of 3 years of experience in Drug Safety/Pharmacovigilance role in the pharmaceutical industry; minimum 4 years for Manager role
• Knowledge and experience with currently available drug safety database systems, document management systems and QC tools. This also includes MedDRA and linked technologies.
• Proficiency in MS Office: Word, PowerPoint, Excel
• Good understanding of clinically relevant ICH GCP guidance, FDA and EMA regulations
• Must be highly organized and detail-oriented, with excellent time management skills
• Excellent oral and written communication skills
• Ability to perform responsibilities with minimal supervision

Salary range:

Sr. Associate – 125,000 – 140,000

Manager -  140,000 – 157,000

Remote only –  115,000 – 135,000

The pay range for this position that we reasonably expect to pay. Individual compensation is based on various factors including, experience, education, skillset, and geographic location. This range is for the Bay Area, California location and may be adjusted to the labor market in other geographic areas.

DISCLAIMER

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.