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Drug Safety Manager

Interim Drug Safety Manager (25%)

Practical Information

• Start: As soon as possible
• Extent: Part-time, approx. 25%
• Duration: Long-term assignment
• Location: Sweden (with flexibility for remote work)

The Role

As Interim Drug Safety Manager / PV, you will be responsible for ensuring that the company’s pharmacovigilance (PV) processes and safety systems meet regulatory standards from clinical phase and onwards. You will take ownership of existing safety data, evaluate current systems, and implement necessary improvements to support ongoing and upcoming studies.

Key responsibilities include:

• Reviewing and assessing existing drug safety data.
• Ensuring regulatory compliance in line with GCP/GVP and relevant health authority requirements.
• Managing collection, assessment, and reporting of adverse events.
• Preparing and submitting DSURs and PSURs within required timelines.
• Coordinating safety data transfer from investigator-initiated studies and other clinical trials.
• Acting as point of contact for authorities regarding safety-related matters.

Your Profile

• Solid experience within pharmacovigilance, preferably from both clinical development and post-approval settings.
• Proven track record of preparing and submitting DSURs and PSURs.
• Strong knowledge of drug safety databases and PV systems.
• Ability to work independently, set up processes, and ensure compliance in a smaller, fast-moving biotech environment.
• Hands-on, structured, and pragmatic approach.