Associate Director, Global Patient Safety Clinical Operations

Takeda Pharmaceutical Company - Lansing, MI

Full-time - Mid Level

Remote - Lansing, MI

Chemical Manufacturing

About the position

The Associate Director, Global Patient Safety Clinical Operations at Takeda is responsible for providing functional expertise and oversight of Pharmacovigilance (PV) activities globally. This role involves managing clinical studies from a PV perspective, ensuring compliance with regulations, and collaborating with various stakeholders to maintain high operational standards. The position is pivotal in identifying risks, supporting audits, and ensuring data quality within clinical trials.

Responsibilities

• Identify potential Clinical Development Program issues/risks and lead discussions to mitigate them.
• Perform daily study-specific activities including SAE reconciliation and study set up.
• Ensure high data quality and efficiency in clinical studies.
• Support study-specific inspection and audit requests.
• Conduct quality reviews of outsourced activities including SAE reconciliation and eTMF filing.
• Review and create study-level documents such as Study Management Plans and Study Safety Summaries.
• Maintain knowledge of PV regulations and global industry practices for operational efficiency.
• Liaise with study teams to ensure compliance with Pharmacovigilance standards.
• Represent Pharmacovigilance Operations on global program/study teams.

Requirements

• Bachelor's degree required; degree in scientific/medical field or advanced degree preferred.
• 8+ years of related pharmaceutical industry experience required.
• Experience in SAE reconciliation and safety management plans.
• Demonstrated skills in negotiation and consensus decision making.
• Expert knowledge of clinical trial and Pharmacovigilance methodologies.
• Good cross-cultural understanding and experience.
• Critical thinking and analytical skills with the ability to make high-level decisions.
• Ability to review, analyze, interpret, and present complex data.
• Understanding of Takeda's business needs and global strategy.
• Excellent organization skills and ability to prioritize workloads.

Nice-to-haves

• Experience in a leadership role within clinical operations.
• Familiarity with global regulatory requirements in Pharmacovigilance.
• Proficiency in Microsoft applications.

Benefits

• Medical, dental, and vision insurance
• 401(k) plan with company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Sick time and paid vacation accrual