Jobs at ProPharma

Manage individual safety case reports (clinical trial and post-marketing), assess seriousness and expectedness, perform MedDRA coding, write medical narratives, follow up for missing information, submit expedited reports per regulations, perform peer reviews, and support training and client notifications.

Senior QA & Compliance consultant providing SME support for Blood & Plasma investigational and commercial products across the EU. Duties include QP-related activities (batch certification), GxP auditing, QMS development, GDP/Responsible Person duties, risk assessments, client training, project delivery and profitability, and promoting CQA services while keeping regulatory knowledge current.

The Compliance & Quality Assurance Consultant manages compliance projects, consulting on quality and regulatory issues while developing QMS and ensuring adherence to GxP regulations.

Provide PV subject-matter leadership for case processing: oversee procedures and agreements, support complex case review and follow-up, create/review narratives, ensure global PV compliance, train and mentor staff, and support client communications.

Provide SME analytical leadership for a pegylated enzyme therapeutic program. Design and manage analytical strategy, lead SEC-HPLC/SEC-HPMC method development and Phase 3 validation, assess analytical risks and mitigations, contribute to project/scientific teams, and support the client across program activities on a remote contract basis (initial 6 months, likely extension).

Perform 3–6 veterinary GCP audits (1–2 days each) in Brazil or remotely. Audit sites against protocol, SOPs, local regulations, VICH GL9 and applicable GLP elements. Auditor schedules dates based on availability. One auditor per audit. Portuguese fluency required.

Oversee and perform daily case processing of adverse events (clinical trial and post‑marketing): MedDRA coding, assess seriousness/expectedness, follow-up, narratives, client notifications, peer review, HCP review, mentor junior staff, and maintain global safety regulation knowledge.

Manage inbound safety communications and mailboxes, perform duplicate searches and initial book-in, redact PHI, facilitate literature and regulatory database triage, draft client reports, enter case data into safety databases, support full data entry with training, help oversee team workload and client deliverables, and perform other assigned pharmacovigilance tasks.

Lead business development to sell CRO and FSP services: build and maintain client relationships, generate leads, create proposals, negotiate contracts, coordinate with internal teams, attend conferences, and manage CRM documentation to drive revenue growth.

Act as the UK Responsible Person (RP/RPI) to establish and manage a WDA/GDP license: lead QMS training, support and lead MHRA inspections, manage storage/cold chain, provide ongoing RP duties (approx. 1 day/week) and be onsite for inspections and key activities.

Author and review aggregate PV reports (PSURs/PBRERs, PADERs, DSURs), RMPs and signal management reports; perform literature searches, data extraction/validation and generate line listings from safety databases; reconcile trackers; support ad-hoc high-priority activities; ensure regulatory compliance and quality, contribute to SOPs/WIs and CAPA activities.

The Compliance and Quality Assurance Consultant manages compliance and QA projects, provides consulting services, and ensures GxP adherence within life sciences. Responsibilities include auditing, QMS development, and training clients while promoting continuous improvement.

The role involves managing user accounts, administering ITSM platforms, improving system performance, and providing technical support, focusing on IT service management best practices.

Sell Clinical Research Solutions by developing long-term client relationships, generating and qualifying leads, writing proposals, negotiating contracts, coordinating with internal teams and marketing, attending conferences, and documenting activities in CRM to drive revenue growth.

Prepare and review U.S. federal, state and international tax returns; handle indirect tax compliance; prepare U.S. GAAP income tax provisions and reconciliations; maintain tax documentation and calendars; support audits and tax authority responses; conduct tax research; monitor tax law updates; partner with finance teams and assist with process improvements and special projects.

Coordinate day-to-day site communications and document submissions for clinical studies. Support screening, recruitment, re-consenting, medical record collection, protocol activities, data entry, query resolution, maintain IRB/FDA-compliant documentation, assist with closeout, and perform other study-related tasks as directed.

Lead business development efforts to sell CRO and FSP solutions: build client relationships, generate leads, write proposals, negotiate contracts, coordinate with internal teams, attend conferences, and track opportunities in CRM to grow revenue.

The GXP Auditor will provide auditing expertise to ensure compliance with regulatory standards in biotech, medical device, and pharmaceutical sectors.

Serve as a Subject Matter Expert in quality assurance and regulatory/GxP for biotech, device, and pharma clients. Manage and consult on CQA projects, ensure project profitability, lead audits, develop QMS and CAPA solutions, support sales and marketing as SME, deliver training, and maintain billable utilization while promoting continual improvement and regulatory compliance.

The VP of Advertising & Promotional Review leads compliance and regulatory advisory services, manages promotional review processes, and collaborates with C-suite executives in pharmaceutical and biotech sectors.