Director, Global Safety and PV Operations

Summary

Join Apogee Therapeutics as their Director, Global Safety and Pharmacovigilance Operations! This critical role oversees all operational aspects of pharmacovigilance, ensuring compliance with global regulations and Apogee's standards. You will manage adverse event reporting, lead safety reviews, and partner with vendors. Success requires strong leadership, cross-functional collaboration, and expertise in drug safety and pharmacovigilance. The position offers a competitive compensation and benefits package, including a base salary, performance bonus, equity grant opportunities, and flexible PTO. Apogee fosters a dynamic and supportive work environment.

Requirements

• Bachelor’s degree in life sciences or related area
• 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
• 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: C aring, O riginal, R esilient and Egoless

Responsibilities

• Manages all operational aspects of pharmacovigilance
• Proactively oversees creation and continuous improvement of adverse event reporting and management processes on a global scale, including the oversight of the case management and regulatory submissions activities
• Leads safety review meetings and oversees global signal detection and surveillance activities for assigned Apogee products
• Partners with vendors for resolution of safety operational issues and questions, identifying vendor training needs and opportunities for improvement and ensuring implementation in collaboration with Apogee stakeholders
• 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(s)
• Oversees the appropriate management of safety management plans (SMP) and other operating procedures with business partners as required
• Provide direction and leadership regarding safety vendor management
• Assist in management of all critical departmental timelines and with budgets for internal and external spend
• Plan and oversee the implementation of database reconciliation in collaboration with Data Management and Apogee business partners as required
• Ensure appropriate documentation by identifying and preparing required written procedures
• Provide operational input into PV SOPs and reviews SOPs from other functions
• Maintain aggregate report schedule, ensure proper SOPs are in place and current to support aggregate report production
• In collaboration with Regulatory Affairs, provide information to be submitted to Regulatory Authorities, maintain and update regulatory reporting rules, ensure timely submission of expedited safety reports, and ensure that submission information is tracked in the safety database
• As required, participate in strategic planning, workflow development, standard operating procedure updates, development & compliance, audits, data analysis and clinical team meetings
• Identify opportunities for process efficiencies and participate in process improvement initiatives
• Provide support to the Quality team and support product complaint activities as needed
• Ensure compliance with FDA regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements

Preferred Qualifications

• Master’s degree or higher preferred
• Working knowledge and experience with European pharmacovigilance regulations preferred

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient 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