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.
Qualifications:
- 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.
