USDM Life Sciences

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

Ensures signal detection, evaluation and management processes meet highest standards by working cross functionally and leading the development of required processes (e.g., with Global Regulatory Affairs, Data Sciences). Ensures that client’s Signal Management processes and activities are compliant with EU regulations and EU regulatory authority and inspectors’ expectations.

Primary Responsibilities

• Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal PSPV stakeholders.
• Represents the pharmacovigilance department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required.
• Ensure compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure patient safety for company’s products.
• Ensure patient safety for company’s products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe.
• Represent all activities related to pharmacovigilance, clinical safety, risk management and signal detection, and report back relevant information regarding status, issues, and/or challenges.
• Strategize and align with the GSLs in developing data analysis strategies and in generating outputs using suitable Pharmacovigilance database retrieval strategies.
• Create visualizations in the form of graphics and tables for regulatory reporting, internal safety updates, signal evaluations and other analysis purposes and product-specific matters.
• Provide input to safety documents and reports to submitted to regulatory authorities.
• Supports inspections and audits related to Signal Management and associated commitments.
• Leads interactions with other PSPV functions including EU QPPV and Global Medical Safety to ensure processes are regularly updated and are fit for purpose.
• Leads interactions with other relevant functional areas both within and outside of PSPV to ensure standards are maintained.
• Participate in training sessions, workshops, and/or conferences, and share knowledge with team members, as agreed.
• Leads training for PSPV and other relevant functions on signal detection processes to ensure training and compliance with processes are maintained.
• Leads interactions and oversight of signal management activities conducted by any vendor.
• Leads interactions with other relevant functional areas both within and outside of PSPV to ensure standards are maintained.
  
  

Additional Responsibilities

• Performs other related duties and assignments as required
  
  

Qualifications

• Excellent communication and interpersonal skills and experience in mentoring others
• Ability to review, analyze, interpret, and present complex data to a high standard.
• Global player in a global PV organization
• Excellent strategic decision-making and analytical skills - Strong leadership skills with excellent track record
• Computer skills including proficiency in use of Microsoft Word, Excel & PowerPoint
• Strong verbal, writing and organizational skills, including a good command of English.
• Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
• In depth knowledge of clinical trial methodology, pharmacovigilance regulations, signal detection and risk/benefit analysis.
• Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities.
• Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)
• Experience with the preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)
• Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
• Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels.
  
  

Education & Certifications

• Graduate degree in health sciences, nursing, pharmacy, public health, epidemiology, or other relevant health-related field (MD, PhD, PharmD, NP, PA, pharmacy, or nursing degree) with at least 5 years of experience in clinical, pharmacological, or related fields of expertise
  
  

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
  
  

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 100.00 - 110.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers