Global Pharmacovigilance Business Systems Analyst
12 Month Contract | Potential to extend
Rate Confirmation | TBD 07/24
We're seeking a Pharmacovigilance Business Systems Analyst to support PV activities related to the geographic expansion of marketed products, with a particular emphasis on regulatory intelligence, safety database configuration, and QMS alignment. This role will serve as a key liaison between the PV Operations team, Safety Systems Management, and the EU QPPV office to ensure country-specific requirements are understood and implemented within PV systems and processes.
While this is a systems-facing role, it is not a highly technical position. This is someone who can work closely with functional SMEs across PV, Regulatory, and Safety Systems gathering requirements, translating business needs into system/process updates, participating in UAT, and ensuring alignment with global PV standards and expansion efforts. Prior hands-on configuration is not required, but strong familiarity with tools like Vault Safety or Argus is important.
location: Telecommute
job type: Contract
salary: $60 - 80 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Monitor and interpret regulatory intelligence for new markets to identify pharmacovigilance obligations (e.g., ICSR reporting requirements, data retention, local authority expectations).
- Translate regulatory requirements into actionable configuration needs for the safety database and collaborate with Safety Systems Management to implement these changes.
- Support the development and maintenance of country-specific configurations, such as reporting rules, distribution pathways, and reference data.
- Liaise with the EU/UK QPPV offices to ensure that country expansion activities align with global PV system and QPPV requirements (e.g., PSMF, local literature monitoring, local contact points).
- Assist with the development, revision, and review of standard operating procedures (SOPs), work instructions, and quality system documentation related to global expansion activities.
- Collaborate cross-functionally to ensure teams are informed of safety database setup timelines, configurations, and regional implementation plans.
- Contribute to inspection readiness by ensuring accurate documentation of configuration decisions and alignment with global QMS standards.
- Support reconciliation and verification activities related to case intake, affiliate partner setup, and regulatory reporting pathways.
- Participate in system user acceptance testing (UAT) and impact assessments for configuration updates as needed.
qualifications:
- Bachelor's degree in life sciences, pharmacy, or a related field
- 5+ years of pharmacovigilance operations experience, with exposure to global expansion or systems integration
- Familiarity with regulatory intelligence and safety reporting requirements across multiple regions (e.g., EU, MENA, LATAM, APAC)
- Experience working with safety databases (e.g., Argus, ArisG, Vault Safety), including understanding of configuration and reporting logic
- Knowledge of quality management systems (QMS), inspection readiness principles, and controlled document management
- Strong collaboration skills with the ability to work across functions, including Information Systems (IS), Safety Systems Management (SSM), PV Operations Regulatory, and QPPV functions
- Excellent documentation, analytical, and communication skills
- Hands-on experience with Veeva Vault (QualityDocs, Vault Safety, or other modules)
- Previous experience supporting PV system configuration projects or geographic expansion activities
- Experience working with EU QPPVs or PSMF support teams
- Familiarity with global PV standards and frameworks (e.g., GVP, ICH E2E, E2B[R3])
- Strong communication and cross-functional collaboration skills
- Demonstrated ability to enhance pharmacovigilance processes by leveraging internal and external insights, staying current with regulatory developments, and applying industry best practices to drive continuous improvement
skills: SOP, Pharmacovigilance, Drug Safety, ICH Regulations, Veeva Vault Safety, Good Pharmacovigilance Practices (GVP), Regulatory Information Management (RIM), Quality Management Systems (QMS)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
