Director, Global Safety and PV Operations

6 days ago

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Apogee Therapeutics

WebsiteLinkedInAll Job Openings

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

Description

•We are seeking a Director, Global Safety and Pharmacovigilance Operations. •This position is responsible for safety/pharmacovigilance operational activities related to clinical use of assigned Apogee products. •Accountable for the successful oversight and execution of deliverables related to case management and aggregate reports. •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. •Manages contract service providers and ensures appropriate documentation is in place to support activities. •Supports aggregate report production and ensures compliance with timely reporting of safety information to Regulatory Authorities to meet regulatory requirements. •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.

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. •Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA. •Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines. •Working knowledge and experience with European pharmacovigilance regulations preferred. •Thorough understanding of Individual Case Safety Reports (ICSR) processing operations required, including working with outsourced vendors and Contract Research Organizations as well as all steps through case receipt, case processing, medical review, and regulatory submission, issuing follow up queries, etc. •Solid knowledge of safety surveillance and aggregate report requirements for clinical trials. •Demonstrated technical, administrative, and project management capabilities. •Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills. •Adaptable to changing priorities. •Proven ability to work in a cross-functional team environment. •Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless. •Position requires approximately 15% travel to All Team meetings and functional meetings.

Benefits

•A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless. •Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. •Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. •Flexible PTO. •Two, one-week company-wide shutdowns each year. •Commitment to growing you professionally and providing access to resources to further your development. •Apogee offers regular all team, in-person meetings to build relationships and problem solve.