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Senior Director of Global Drug Safety
2 months ago
Advanced Recruiting Partners is seeking a highly experienced Senior Director of Global Drug Safety to lead our drug safety team. As a key member of our leadership team, you will be responsible for developing and implementing our drug safety strategy, ensuring compliance with global regulatory requirements, and overseeing the collection, evaluation, and analysis of adverse event data.
Key Responsibilities- Strategic Leadership:
- Develop and implement the company's drug safety strategy and ensure alignment with corporate goals.
- Provide strategic guidance on drug safety and pharmacovigilance to senior management and other departments.
- Regulatory Compliance:
- Ensure compliance with global regulatory requirements for drug safety and pharmacovigilance.
- Oversee the preparation and submission of safety reports to regulatory agencies.
- Safety Management:
- Lead the development and maintenance of drug safety policies and procedures.
- Oversee the collection, evaluation, and analysis of adverse event data.
- Ensure timely and accurate reporting of safety information to internal and external stakeholders.
- Team Leadership:
- Build, manage, and mentor a team of drug safety professionals.
- Foster a culture of continuous improvement and high performance within the safety department.
- Cross-Functional Collaboration:
- Collaborate with clinical development, regulatory affairs, and other departments to ensure integrated safety strategies.
- Provide safety input into clinical trial designs and post-marketing activities.
- Risk Management:
- Develop and implement risk management plans and risk minimization strategies.
- Analyze safety data to identify potential risks and recommend mitigation strategies.
- External Relations:
- Represent the company in safety-related discussions with regulatory authorities, industry groups, and other external stakeholders.
- Stay informed about industry trends, regulatory changes, and best practices in drug safety.
- Budget and Resource Management:
- Manage the drug safety budget and allocate resources effectively.
- Ensure the department operates efficiently and within budgetary constraints.
- Advanced degree (Ph.D., MD, or PharmD) in a relevant field.
- Extensive experience in drug safety, pharmacovigilance, or a related field within the pharmaceutical industry.
- Proven track record of leadership and management in a drug safety role.
- Strong understanding of regulatory requirements and industry standards for drug safety.
- Excellent leadership, communication, and interpersonal skills.
- Ability to analyze complex data and make strategic decisions.
- In-depth knowledge of drug development processes, risk management, and safety reporting systems.
- Familiarity with global regulations and guidelines related to drug safety.