myTomorrows

Health Tech

RegulatoryAffairsPharmacovigilanceManager

€85–125k ~AI est. Amsterdam, Netherlands FULL TIME Remote Friendly
The Brief

“Regulatory Affairs Pharmacovigilance Manager at myTomorrows. Skills: Regulatory Affairs, Pharmacovigilance, Expanded Access. Support regulatory strategies for EAPs. Act as RA/PV expert”

Industry & Context.

Health Tech
Problems you'll solve

Proactive problem solver; Identify challenges; Suggest solutions

What They're Looking For.

Must Have

5 years relevant experience, Working knowledge of Pharmacovigilance, Solid understanding of legislation, Bachelor's or Master's degree, Experience with clients/external stakeholders, Microsoft 365 tools proficiency

Nice to Have

Knowledge of additional languages

What You'll Do.

Support regulatory strategies for EAPs

Prepare regulatory dossiers for EAPs

Provide input for EAP strategy

Collaborate with Commercial team

Ensure compliant handling of regulatory activities

Stay up to date on global laws

Assist in drafting documentation

Liaise with Pharmacovigilance provider

Contribute to maintaining department documentation

How You'll Work.

Team & Collaboration

Working with Medical Affairs; Working with Program Management; Working with Quality Assurance; Working with Supply Chain; Cross-functional environment

Communication Scope

Convey complex topics

Free ATS check

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