Senior Pharmacovigilance Director for Global Biotechnology Company

3 weeks ago


Los Angeles, California, United States Lifelancer Full time
About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. is a well-funded, Nasdaq listed biotechnology company offering opportunities to work in a fast-paced and dynamic environment. At Apogee, you can contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

We are a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications with high unmet need. Our antibody programs aim to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.

We believe people living with these diseases deserve the best possible treatment, and we refuse to stop at "good enough."

We are committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient, and Egoless.

Job Description

The Senior Pharmacovigilance Director will be responsible for safety/pharmacovigilance operational activities related to clinical use of assigned Apogee products. This position ensures individual safety reports from clinical trial sources are collected, managed, and reported according to Apogee's SOPs and global adverse event regulations and guidelines.

This role is critical to support the overall global safety surveillance program to ensure the proper management of the benefit risk profile of Apogee's products. It is equally important to ensure compliance with global regulatory requirements and Apogee's policies and standards.

Key Responsibilities:
  • Manage all operational aspects of pharmacovigilance.
  • Proactively oversee creation and continuous improvement of adverse event reporting and management processes on a global scale.
  • Lead safety review meetings and oversee global signal detection and surveillance activities for assigned Apogee products.
  • Partner with vendors for resolution of safety operational issues and questions, identifying vendor training needs and opportunities for improvement.
  • Accountable for effective oversight of outsourced operational activities, measuring vendor performance through Key Performance Indicators/Metrics according to Apogee standards and contracted Service Level Agreements.
Requirements

Bachelor's degree in life sciences or related area, Master's degree or higher preferred.

Minimum 8 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance.

At least 4 years of experience in leading cross-functional teams and/or PV related deliverables and initiatives.

What We Offer

A market competitive compensation package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.

Flexible PTO and two one-week company-wide shutdowns each year.

Ongoing professional development opportunities and resources to further your career.



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