Pharmacovigilance Applications Manager


July 20, 2021

Pharmacovigilence Applications Manager, HSGBU (Health Science Global Business Unit)
Under the guidance of the Sales Director of the West BU, Oracle is seeking to recruit an outstanding candidate for a PV software applications specialist to manage and promote Safety applications into the Emerging Biopharma, Med Device and small-mid size CRO markets in the West US. The specialist will be responsible for selling Oracle's Pharmacovigilance(Safety) software solutions, incl. Argus, Empirica and Safety One Intake.
Key skills / experience required;
  • 5 - 10 years in sales with Software Applications and/or clinical trial-related products or services
  • Consistent track record of exceeding quota
  • Life science industry experience and knowledge, particularly in the area of pharmaceutical safety.
  • Excellent prospecting and qualification skills to identify new opportunities
  • Strong software sales background, with proven track record of closing complex software sales cycles
  • Ability to think strategically about the market and prioritize key growth opportunities
  • Ability to penetrate accounts at multiple levels and clearly articulate Oracle Health Science’s value proposition
  • Build and nurture lasting relationships with key stakeholders
  • Needs to be a team player with strong interpersonal /communication skills
  • Excellent customer communication (external & internal), negotiating and closing skills
  • Ability to sell directly to end customers, while also working with industry channel partners to close deals
  • Highly organized and deadline orientated, with experience of producing regular sales forecast reports and activity updates
  • Knowledge of clinical trial and PV methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements in PV
  • Strong experience in the conduct and management of clinical trials throughout the clinical trial phases.
  • Strong background in clinical trial drug safety.
  • An understanding of medical terminology and ability to summarize medical information is a plus.
  • Personnel management experience is a plus.
  • Strong attention to detail and follow-up skills is necessary for success.
  • Must be flexible and willing to take on significant administrative responsibilities.
  • Must take initiative and have ability to work independently and as a team member, offering assistance wherever needed.
  • Must be able to create contingency plans to deal with possible challenges and roadblocks.
  • Good computer and database skills, familiarity with ARGUS platform is preferred.
  • Extremely strong team collaboration competencies are a must.

Reportin to the Director of Sales and covering the Western half of the US and Canada the primary role is to manage and promote business applications software/solutions and related services to prospective and existing customers. Manage sales through forecasting, account resource allocation, account strategy, and planning. Develop solution proposals encompassing all aspects of the applications and addressing customer needs. Participate in the development, presentation and sales of a value proposition. Negotiate pricing and contractual agreements to close the sale. Identify and develop strategic alignment with key third party influencers. Must be able to use MS Office products: Excel, Word, PPT.
  • Create and adapt pharmacovigilance procedures based on prevailing domestic and international regulations, VRC polices/procedures, etc.
  • Review safety events for completeness and trends; analyze comprehensive safety data in consultation with PV team; communicate findings.
  • Participate on cross functional, multidisciplinary teams and contribute to defining aggregate reporting guidelines.
  • Draft, review and finalize PV data agreements with collaborators who receives manufactured investigational products.
  • Work with external partners to gather PV information/data and review it utilizing the PV data system platform (ARGUS).
  • Author/provide strategic input or oversight for PV related sections of periodic regulatory documents (i.e. IND annual reports, DSURs, IB updates) according to the agreed process and timelines.
  • Monitor and evaluate safety profiles of VRC manufactured investigational products to detect any change in risk profile.
  • Collaborate with protocol operations, medical, quality and risk management teams to ensure coordinated and effective risk mitigation strategies throughout the product lifecycle.
  • Assign projects and set deadlines for PV Team staff and facilitate PV team meetings.
  • Maintain knowledge of vaccine and monoclonal antibody safety profiles and product development status; review relevant biomedical literature or other scientific data.

  • 100% Medical, Dental & Vision premium coverage for Employees
  • Paid Time Off (Including Holidays)
  • Employee Referral Bonus
  • 401K Match
  • Tuition reimbursement and professional development opportunities
  • Flexible Spending Accounts:
  • Healthcare (FSA)
  • Parking Reimbursement Account (PRK)
  • Dependent Care Assistant Program (DCAP)
  • Transportation Reimbursement Account (TRN)
  • Paid Expenses

Oracle Health Sciences Summary;
The Health Sciences Global Business Unit (HSGBU) was formed within Oracle in 2008, to focus on developing and selling software specifically for the specialized needs of Healthcare and Life Sciences companies. Over the last 12 years the HSGBU has led the eClinical market and is consistently recognized as the market leader. In 2020, For the fourth straight year, Oracle Health Sciences was named a “Leader” in the Everest Group Clinical Development Platforms Products PEAK Matrix® Assessment 2020. Oracle Health Sciences maintained its position as the highest positioned vendor in “Vision and Capability” and took the highest position for “Market Impact.”
Clinical Research product summary;
Pharmacovigilance product summary;
Working within a Global Business Unit Sales team offers a high degree of personal autonomy, but requires excellent self-organization and self-motivation. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans status or any other characteristic protected by law.
Job Type: Full-time
Pay: $120,000.00 - $160,000.00 per year
  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Disability insurance
  • Employee assistance program
  • Flexible schedule
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Parental leave
  • Retirement plan
  • Vision insurance

  • 8 hour shift

Supplemental Pay:
  • Commission pay

Application Question(s):
  • Do you currently reside in the Western US?
  • What skill sets might you have in cross collaborative team coordination? Ie....working with other cross functional associates and divisions.

  • Bachelor's (Preferred)

  • Safety Software Application: 5 years (Preferred)

Willingness To Travel:
  • 50% (Preferred)

Work Location:
  • On the road

Work Remotely:
  • Yes