Senior Drug Safety Associate II

MSI Pharma; United States; On-site; USD 68,880 - 77,145; Part time

Benefits offered by this job

Medical insurance

Job summary

A leading biotechnology company is seeking a Senior Delivery Consultant for HR, Finance & Quality to support their Global Patient Safety Quality Management Operations. The ideal candidate will have over 5 years of pharmacovigilance experience, expertise in quality management, and proficiency in Veeva Quality. This contract position offers a competitive pay range, focusing on maintaining compliance with global regulations. Medical insurance is included as a benefit.

Responsibilities

• Develop, revise, and maintain GPS procedural documents.
• Manage the Global and Local PSMFs, ensuring accuracy.
• Collaborate with GPS teams to harmonize documentation.
• Provide guidance on PSMF strategy and documentation.
• Conduct quality control checks and coordinate workflows.
• Drive global harmonization of PV procedures.

Skills

Pharmacovigilance experience

PV quality management

Cross-functional collaboration

Veeva Quality proficiency

Education

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field

Job description

Senior Delivery Consultant For HR, Finance & Quality (Pharma, Biotech & Med Devices)

Pharmacovigilance Quality & PSMF Specialist (Contract)

We’re supporting a Global Biotechnology leader seeking an experienced professional to join their Global Patient Safety (GPS) Quality Management Operations (QMO) team. This contract role plays a key part in maintaining the Global Patient Safety Quality Management System, ensuring compliance with worldwide pharmacovigilance (PV) regulations.

Key Responsibilities

• Develop, revise, and maintain GPS procedural documents, policies, and the Pharmacovigilance System Master File (PSMF).
• Manage the Global and Local PSMFs, ensuring timely updates, accuracy, and regulatory compliance.
• Collaborate with cross‑functional GPS teams to harmonize documentation and support consistent application of company standards.
• Provide expert guidance on PSMF strategy and documentation best practices.
• Conduct quality control checks, coordinate PSMF workflows in Veeva Quality, and support audits and inspections as a PSMF subject matter expert.
• Drive global harmonization of PV procedures and resolve procedural document‑related issues.

Required Skills & Experience

• 5+ years’ pharmacovigilance experience in operational roles, with strong understanding of global PV and regulatory frameworks.
• 3+ years’ experience in PV quality management, standards, or PSMF oversight.
• Proven cross‑functional collaboration skills and experience managing complex documentation processes.
• Proficiency in Veeva Quality.

Education

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field (advanced degree preferred).

This is an exciting opportunity to contribute to a world‑class pharmacovigilance organization ensuring patient safety and regulatory excellence.

Benefits

Medical insurance

Seniority level

Mid‑Senior level

Employment type

Contract

Job function

Science

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Research Services

Base pay range: $50.00/hr - $56.00/hr