Drug Safety & Pharmacovigilance

Orbis Clinical’s pharmacovigilance staffing services provides experienced dedicated consultants within drug safety, pharmacovigilance and risk management to augment existing teams, outsource spikes in workload, or to bring an added level of subject matter expertise to your organization.

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Bringing PV Back In-House? Orbis Has You Covered

  • Navigate global safety requirements
  • Build agile and scalable PV teams
  • Respond quickly and precisely to evolving regulations

The Orbis Difference

Reducing Time-to-Fill Without Sacrificing Fit

We pride ourselves on delivering candidates who not only meet the mark - but accept the offer. With an offer-to-close rate over 95%, we consistently deliver candidates who are both highly qualified and genuinely motivated, because we understand what matters both side sides.

Contractor Retention: A Core Strength at Orbis Clinical

We recognize that success in pharmacovigilance doesn’t stop placing the right talent it’s about keeping them engaged, productive, and aligned with your goals.

Where the Industry Meets, We're There

Our active presence at global PV and biotech conferences such at WDSC- Boston keeps us at the forefront of industry evolution. Our clients benefit from sharper insights and stronger talent connections.

Pharmacovigilance Operations

  • Supporting both clinical, and post marketing products- Triaging, Data Entry of SAEs/AEs, MeDRa Coding, Case processing, narrative writing, QC of cases
  • Litigation Case Support - medical records review for causality
  • Scientific Literature Review
  • PV Compliance
  • PV Auditing (audit prep, and audit work both domestic and international)
  • Database SMEs (Clintrace, Argus, ARISg, RAVE)
  • Vendor Management, SDEA, CAPAs

Pharmacovigilance Physician Level Support

  • Individual Medical Case Review/ICSR Review
  • Aggregate Data Review
  • Risk Management Activities
  • Signal Detection Activities
  • Submission Writing
  • Ad hoc response
  • Liaison to International Regulatory Agencies

Pharmacovigilance Operations

  • Safety Report Writing/Aggregate Report Writing (DSUR, PSURs, PBRERs)
  • Risk Management Plans (RMP)
  • Signal Detection Activities
  • Medical Writing
  • CSRs, Narratives

What people are saying about Orbis Clinical

Great team to work with. Orbis team cares about the need of the employees every step of the way not just at the start.
Archana M.Google
Myles was my recruiter contact Orbis and he was great ever since he brought this opportunity. He was well informed of the role and exlplained and understood how my experience pertains to the role. He was very responsive and always ready to answer any questions I had.
Clinical Study SpecialistGlassdoor
Professional, Friendly, Supportive, Consistent, Responsive, Follows up and doesn’t leaving you hanging!
Manager, Quality ManagementGlassdoor

Ready to Strengthen Your Safety Team?

Talk to our team about your drug safety and pharmacovigilance staffing needs, or call us at (781) 328-1132.