Senior Manager/Assoc Director, Safety Operations

Position Summary:  

Reporting to the Director, Safety Systems & Quality, the Senior Manager or Associate Director, Safety Operations provides oversight and management of vendors, business partners, and individuals involved with the Individual Case Safety Report (ICSR) process to ensure efficiency, quality, and compliance with internal procedures and global regulations. They also oversee global safety database activities including serious adverse event reporting metrics, support individual study teams, and collaborate on the support of risk management and pharmacovigilance for all Erasca clinical trials. Additionally, the Senior Manager or Associate Director, Safety Operations leads the planning, execution, and implementation of process improvements and procedures related to ICSR reporting.

Essential Duties and Responsibilities:  

• Responsible for performing vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent, and compliant manner.
• Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated program management personnel at the vendor site(s).
• Responsible for the facilitation of training and development of vendor personnel (remotely) , driving the development of self-sufficiency at the vendor level.
• Manage Vendor Oversight including tracking of KPIs, metrics, and on-time reporting.
• Ensure safety reports received from clinical trials are processed in a consistent and fully compliant manner.
• Oversee SAE/SUSAR reporting activities for all investigational drugs (Maintain oversight to ensure Global clinical trials case reporting process is efficient and compliant with worldwide reporting requirements).
• Ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements detailed in the safety management plans (SMP)/ PV agreements and safety data exchange agreements.
• Point of contact for key stakeholders for safety-related activities within the SMPs and PV agreements.
• Lead preparation of safety-reporting/management plans with partners and CROs (i.e., SMPs and PVAs).
• Participate and contribute to Study Management Team (SMT) meetings.
• Provide guidance and support to project teams for safety reporting-related areas, including protocol development and study conduct.
• Oversee reconciliation activities with other departments and vendors for Erasca products
• Supports the development of Erasca Global Patient Safety infrastructure, including new safety projects..
• Lead and/or contribute to the creation and approval of PV SOPs and Work instructions.
• Drive the resolution of PV vendor’s deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs and/or SOPs.
• Participate in regulatory inspections and PV audits to ensure the quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations.
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations. 

Required Education and Experience: 

Minimum Requirements:  

• Master’s degree in a relevant life sciences field, advanced nursing degree, or pharmacy degree is highly preferred; for exceptional candidates, a Bachelor of Science combined with relevant experience will be considered, or comparable experience.
• A minimum of 5 - 8 years of experience in pharmacovigilance with a focus on operations is required.
• Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal Regulations; European Union GVP legislation; and ICH Guidelines)
• Experience participating in quality inspections and audits.
• Proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines.

Desired:  

• Experienced in pre-approval/clinical development pharmacovigilance safety reporting requirements.
• Project management experience implementing processes and solutions for pharmacovigilance, safety report, and data analytics.
• Experience with data entry of drug safety databases, such as Oracle Argus.
• Experience in data outputs preparation for performing drug safety reports including periodic reports (DSUR, and/or PBRER).
• The ideal candidate will have experience in a startup environment developing and implementing pharmacovigilance standards, processes, and procedures for quality oversight.
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
• Able to work in an entrepreneurial, fast paced, dynamic, team-oriented environment.
• Strong oral and written communication skills.
• Strong learning orientation, curiosity, and commitment to science and patients.

The anticipated salary range for this position is $175,000 to $202,500. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.