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Senior Manager
2 months ago
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. As the world’s largest RCO (Research Consulting Organization), 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.
The Senior Pharmacovigilance Manager, Regulatory Intelligence (RI) & Submissions position is responsible for maintaining and growing the RI repository and global submission capability in support of the Pharmacovigilance service line. Drives the long-term vision, strategic targets, and operational goals for the RI and Submissions teams.
Regularly informs management regarding issues, progress, and developments within the RI and Submissions groups.
Manages direct reports including 1:1 meetings, performance reviews, frequent coaching, and redirection of activities as needed.
Oversees the cohesion between various activities within the RI and Submissions groups and overall PV business to improve efficiency, effectiveness, and quality.
Identifies problems, risks, and bottlenecks in work processes and drive change to resolution while mitigating client, regulatory, and company risks.
Conducts negotiations for complex and sensitive projects with at large clients or commercial partners and manages as such within the RI and Submissions groups.
Identifies changes needed to improve client satisfaction and provide oversight of quality and compliance.
Coordination of regulatory submission team.
Dissemination of Regulatory Intelligence information and training as needed for staff.
Quality investigations for RI and Submissions related activities.
Must have at least 5-10 years or more exposure to clinical and/or post-marketing Pharmacovigilance
Expert knowledge of global pharmacovigilance practices and regulatory requirements.
Fluency in English
Proficient organization, prioritization, and project management skills
We are committed to diversity, equity, and inclusion. Please, no phone calls or emails to anyone regarding this posting.***
