Regulatory Safety Lead (Global Pharmacovigilance Head-Level) – Remote Contract | ProPharma Careers
About ProPharma
ProPharma is a global consulting organization with over 20 years of experience supporting pharmaceutical, biotechnology, and medical device companies. Through its advise-build-operate model, the company delivers end-to-end solutions across regulatory sciences, clinical research, pharmacovigilance, medical information, quality & compliance, and R&D technology. ProPharma partners with global life sciences organizations to de-risk development programs and accelerate the delivery of safe and effective therapies.
Job Overview
ProPharma is seeking a highly experienced Regulatory Safety Lead to support global pharmacovigilance and regulatory safety leadership activities. This is a senior-level contract role requiring deep expertise in global drug safety operations, regulatory authority interactions, and late-stage clinical development support. The position plays a critical role in supporting a 2026 NDA submission and overseeing strategic pharmacovigilance functions.
Job Type & Work Model
Role: Regulatory Safety Lead (Pharmacovigilance Leadership)
Work Mode: Remote
Engagement Type: Contract
Duration: 6+ months
Key Responsibilities
Provide strategic leadership across global pharmacovigilance and drug safety operations
Oversee case management, safety surveillance, signal detection, and risk management activities
Lead benefit–risk assessment and pharmacovigilance quality system governance
Serve as the primary representative for interactions with FDA and other global regulatory authorities
Support and lead regulatory inspections and safety-related authority communications
Drive PV strategy for late-stage development programs and NDA/BLA submissions
Support and contribute directly to 2026 NDA submission activities
Build, scale, and optimize pharmacovigilance systems and infrastructure for commercialization readiness
Ensure global compliance with applicable pharmacovigilance regulations and guidelines
Provide leadership oversight of PV operational teams and quality systems
Required Skills and Competencies
Strong leadership experience in global pharmacovigilance and drug safety functions
Expertise in regulatory authority interactions (FDA, EMA, and other global agencies)
Deep knowledge of pharmacovigilance systems, safety governance, and risk management frameworks
Strong experience in late-stage clinical development and regulatory submissions
Ability to design and scale PV infrastructure for commercial readiness
Strong strategic thinking, decision-making, and cross-functional leadership skills
Excellent communication and stakeholder management at executive and regulatory levels
Proven ability to operate in high-pressure, regulatory-critical environments
Educational Qualifications
Medical Degree (MD) is mandatory
Experience Requirements
Minimum: 15+ years of progressive pharmacovigilance and regulatory safety experience
Required: Prior experience as Head of Pharmacovigilance or Global Drug Safety in a large pharmaceutical company or established biotech
Strong preference for candidates with direct FDA interaction and inspection leadership experience
Must have experience supporting NDA/BLA submissions and late-stage development programs
Why Join ProPharma
Opportunity to lead high-impact global pharmacovigilance strategy
Direct involvement in NDA submission and commercialization readiness
Remote, flexible contract engagement
Collaboration with global regulatory and drug safety experts
Exposure to high-profile pharmaceutical and biotech development programs
Diversity, Equity, and Inclusion
ProPharma is committed to fostering a diverse and inclusive workplace where individuals can bring their authentic selves to work. The organization values innovation, collaboration, and equal opportunity, ensuring a safe and empowering environment for all employees and consultants.
Application Process
All applications are reviewed by ProPharma’s recruitment team. Candidates receive direct communication regarding outcomes. The company does not use AI-based screening tools in hiring decisions.
Important Notice
ProPharma does not accept unsolicited resumes from third-party recruiters. Direct phone calls or emails regarding this role are not permitted.
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