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Senior Vice President of Safety Operations
2 months ago
FTE Role - Hybrid Work Environment
W2 Employment Only
POSITION OVERVIEW
The Vice President of Safety and Pharmacovigilance will be responsible for directing all facets of clinical and commercial drug safety and operational safety for Milestone Technologies, Inc. This role demands a leader who can manage a safety division and collaborate effectively with a multidisciplinary team, including clinical, regulatory, scientific, biometrics, operational, and commercial professionals, while also engaging with external vendors, experts, investigators, and regulatory bodies.
KEY RESPONSIBILITIES
- Oversee all medical safety elements associated with clinical development and post-market surveillance of the company's medicinal products.
- Direct both medical safety and operational safety for clinical and commercial products.
- Ensure quality and timeliness of vendor deliverables related to safety and pharmacovigilance for clinical initiatives and marketed products.
- Provide strategic oversight and comprehensive responsibility for commercial safety reporting obligations across various regions.
- Lead, mentor, and manage a team with a strategic vision for future development and operational planning.
- Collaborate with clinical development teams to assess safety signals and validate findings.
- Engage in interactions with health authorities regarding safety risk management and oversee team members involved in these discussions.
- Manage Drug Safety Committees and Core Safety Information.
- Develop and oversee safety strategies for regulatory communications and support submission processes.
- Contribute to written safety summaries and reviews for clinical protocols, regulatory submissions, and other key documents.
- Supervise the writing and review of periodic safety reports.
- Oversee case processing and medical review of safety reports and follow up with investigators as necessary.
- Conduct Benefit-Risk Assessments in partnership with Clinical Development as needed.
- Ensure adherence to global safety regulations and maintain inspection readiness, including conducting root-cause analyses.
- Manage relationships with clients and team members, providing expert safety insights.
QUALIFICATIONS
- Education/Experience: MD or PharmD with significant experience in safety and pharmacovigilance within the biotechnology or pharmaceutical sectors, with a minimum of 10 years in the industry.
- Proven experience in team building and project leadership.
- Expertise in risk management and signal detection methodologies.
- Comprehensive understanding of global pharmacovigilance standards.
- Experience managing safety and pharmacovigilance vendors.
- Familiarity with regulatory authority inspections.
- Ability to formulate high-level safety strategies while also engaging in detailed operational tasks for clinical and commercial products.
- Strong business acumen and capacity to collaborate with cross-functional teams to achieve organizational objectives.
- Excellent written and verbal communication skills, with a focus on relationship building.
- Demonstrated track record of strategic planning and execution across multiple projects, with the ability to prioritize effectively.
- Highly organized, detail-oriented, and capable of meeting deadlines in a dynamic environment.
- Able to work autonomously and independently.
- Knowledge of regulatory requirements for product approval and compliance in the US and Europe.
COMPENSATION:
The anticipated salary range for this position is USD $375,000 - $400,000 per year, classified as an exempt role.
Compensation and employment offers will be determined based on individual qualifications, skills, experience, and other relevant factors.
