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

Very responsive, quality candidates, and great to work with.

Client

ClearlyRated

I love working with Orbis; they understand the requirements for the role very well and thoroughly vets the candidate before sending their CV. Thanks for going an extra mile and checking in on the candidate's performance once hired.

Client

ClearlyRated

Heidi has been an exceptional recruiter over the years. She has consistently found me great roles, demonstrating an uncanny ability to identify the right fit. She also has a great attitude and is incredibly easy and pleasant to work with.

Xan P.

Google

Contact Us

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