Regulatory Safety Lead (MD)

This a Full Remote job, the offer is available from: Maryland (USA) For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Job Requirements

• Regulatory Safety Lead (will be taking on many of the responsibilities that the current PV Head drives)
• MD required; must have previously served as Head of Pharmacovigilance / Global Drug Safety (large pharma or well‑established biotech strongly preferred).
• 15+ years of progressive experience in pharmacovigilance and regulatory safety within the biotechnology or pharmaceutical industry.
• Deep, hands‑on experience representing organizations to the FDA and other global regulatory authorities, including ownership of safety interactions and inspections.
• Proven leadership overseeing global PV operations, including case management, safety surveillance, risk management, benefit–risk assessment, compliance, and PV quality systems.
• Demonstrated experience supporting late‑stage development and NDA/BLA submissions; this role will directly support our 2026 NDA submission.
• Track record of building, scaling, and governing fit‑for‑purpose PV processes and infrastructure in preparation for commercialization.
• Remote Working, Contract opportunity 6+ months in duration

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*

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