# Pharmacovigilance Consultant (Risk Management Plans) - Zero-Hour Contractor

**Company:** [Quanticate](http://jobs.workable.com/companies/i2x94yqqk4sxTNQaZMnKDJ.md)
**Location:** Remote
**Workplace:** remote
**Employment type:** Contract
**Department:** Pharmacovigilance

[Apply for this job](http://jobs.workable.com/view/594a9401-8c2a-4b7d-b05c-e05928cfcd6a)

## Description

We are seeking an experienced Pharmacovigilance Consultant to provide specialist support in the development, authoring, and maintenance of Risk Management Plans (RMPs) across global markets. This is a flexible, zero-hour contract opportunity suited to an independent consultant with extensive regulatory and pharmacovigilance expertise.

The successful candidate will play a key role in supporting both Marketing Authorisation Applications (MAAs) and post-approval lifecycle activities, ensuring high-quality, compliant RMP documentation aligned with regional regulatory requirements.

### Key Responsibilities

-   Lead the preparation, authoring, review, and updating of Risk Management Plans (RMPs) for regulatory submissions and post-approval activities.
-   Develop RMPs in support of Marketing Authorisation Applications (MAAs) and variations.
-   Ensure RMPs comply with regional pharmacovigilance and regulatory requirements.
-   Collaborate with cross-functional teams including Regulatory Affairs, Clinical Development, Medical Affairs, Safety, and Quality.
-   Provide strategic pharmacovigilance input regarding safety concerns, risk minimisation measures, and pharmacovigilance activities.
-   Support responses to health authority questions related to risk management and pharmacovigilance documentation.
-   Contribute to the continuous improvement of pharmacovigilance processes and documentation standards.

## Requirements

### Essential Requirements

-   Advanced degree in Life Sciences, Pharmacy, Medicine, or a related discipline.
-   Significant experience in pharmacovigilance and drug safety within the pharmaceutical, biotechnology, or consulting sector.
-   Demonstrated expertise in authoring and maintaining Risk Management Plans (RMPs).
-   Proven experience supporting both:

-   Marketing Authorisation Applications (MAAs)
-   Post-approval pharmacovigilance activities

-   Strong knowledge of global pharmacovigilance regulations and risk management frameworks.
-   Experience preparing RMPs for the following markets:

-   EU

-   Japan
-   South Korea
-   China
-   Brazil

-   Excellent scientific writing, communication, and stakeholder management skills.
-   Ability to work independently and manage multiple projects within agreed timelines.

### Desirable Requirements

-   Experience in development of Pre-IND (Investigational New Drug) RMPs.
-   Experience with additional regional risk management documentation requirements beyond the specified markets.
-   Previous consulting or contractor experience within a global environment.