Drug Safety & Pharmacovigilance

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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Find out how Orbis Clinical can help you

Talk to Our Business Development Team

How our pharmacovigilance staffing services can help your team

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

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 Specialist

Glassdoor

Professional, Friendly, Supportive, Consistent, Responsive, Follows up and doesn’t leaving you hanging!

Manager, Quality Management

Glassdoor

Contact Us

Fill out the form below to get in touch with our business development team, or call us at (781) 328-1132.