Associate Director, Drug Safety Operations and Compliance

Who We Are: 

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives.  Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science, and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

The Associate Director, Pharmacovigilance Operations is responsible for overseeing operation activities with multiple CROs to ensure effective, high quality and efficient management of processes, cases and operations staff complying with EU and US regulatory timelines. The candidate should demonstrate understanding of Pharmacovigilance Operations and work collaboratively and/or independently to demonstrate effective project management/leadership skills with cross-functional teams to ensure compliance and efficiency per regulatory guidance and SOPs. They should be able to manage multiple studies with changing priorities and can work in a matrix environment. They will manage Calico’s Strategic PV Partnerships and contracts including vendor outsourcing agreements, Safety Data Exchange Agreements (SDEAs), and all PV contractual agreements to ensure appropriate PV relevant and AE reporting language is captured. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements.

Position Responsibilities:

• Demonstrate knowledge of Pharmacovigilance Operations and GCP/ICH regulations and guidelines to meet PV compliance
• Lead inspection readiness activities and serve as subject matter expert (SME) for audits and inspections, as well as ensure preparedness for all safety-related documentation to be filed properly for inspection
• Review and analyze audit, inspection and CAPA data to identify compliance trends and areas of exposure related to GCP and PV
• Work closely with department head, internal and external stakeholders, and Quality Assurance/Regulatory to implement and maintain an effective and compliant system for monitoring the safety profile for individual compounds as well as the platform
• Collaborate with the global Quality Assurance team to conduct inspection readiness training, one-one practice sessions and mock audits as needed
• Drive CAPA implementation with vendors and partners
• Develop new Standard Operating Procedures (SOPs)/Work Instructions (WI) and periodically review existing SOPs/WI for PV function to determine the need for changes and updates of existing documents and the initiation of new procedural documents
• Be accountable for identification, initiation, development and implementation of PV process improvements, tools, systems, and procedures to ensure quality and consistency in safety operations, data output, studies, and programs
• Ensure the MedDRA upgrade process is well defined and timely upgrades are completed
• Participate in bid defense and lead the process of safety CRO selection and evaluation process as needed
• Manage the Safety database development and transition activities
• Manage CROs to ensure all timelines are met, potential issues are being communicated, and resolution is achieved in a timely manner
• Collaborate with the case processing team at CRO and develop and report internal tracking metrics related to case processing team at CRO, consultants and/or in-house clinical trial SAE processing and vendor management
• Responsible for vendor oversight and development of Key Performance Indicators (KPIs) for vendor assessment
• Be accountable and responsible to ensure the Business Continuity Plan (BCP) is maintained by the CRO, aligns with our current practices, is updated as necessary, and is tested annually and documented/archived
• Ensure safety management plan (SMP) is in place for each assigned study, as well as review relevant eCRF forms from clinical database for alignment with safety forms and reconciliation (e.g., AE, study drug administration, disposition)
• Ensure PV representation during site initiation visits, investigator meetings, CRA training and site calls
• Ensure registration of product study/CRO personnel as required with ex-US reporting (e.g., Eudravigilance) and SUSAR submission compliance with applicable FDA and global regulations, as well as internal client SOPs
• Participate and manage the Safety Meetings based on the study specific requirements or aggregate reviews
• Provide operational support for signal management/Joint Safety activities/Safety Review Board meetings, including monthly meetings, action item tracking, and ensuring adequate documentation
• Be responsible for management of literature review for molecules and ensuring documentation and archival
• Provide guidance and appropriate study configuration to safety data management for SAE/AE reconciliation process
• Ensure all protocol defined PV deliverables are completed prior to database locks 
• Assist in single case & end-of-study unblinding, deviation memo preparation, deletion/admin edit requests and approvals, review protocol update request forms for accuracy
• Support and guide interim coding review of AEs and concomitant medications (CMEDs) as outlined in study-specific plans
• Author and train on the SOPs as required per job function
• Lead the budget planning for the safety operations function, report on ongoing budget initiatives, and manage the budget and forecasting activities with the CROs
• Develop and support with training of new hires

Position Requirements:

• Bachelor of Science degree required, graduate degree in a scientific discipline or

healthcare profession is desirable

• Minimum of 7 years of Pharmacovigilance Operations experience in a biopharma company in both clinical trial and post marketing environments
• A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP
• Experience with safety databases (i.e., Argus) and safety coding dictionaries (i.e., MedDRA, WHODRUG); Spotfire and Rave/Medidata are a plus
• Effective project management skills with a demonstrated ability to provide critical and timely insight and analytical problem-solving skills with a broad perspective
• Strong attention to detail in establishing priorities, scheduling, and meeting deadlines
• Thorough understanding of the clinical drug development process
• Excellent interpersonal skills, organizational and decision-making skills, and ability to adapt to a dynamic and complex regulatory and business environment while working with cross functional teams
• Flexibility and agility to function on various levels of the role as required in a fast-growing environment
• Ability to travel up to 20% of the time domestically and internationally
• Must be willing to work onsite at least four days per week

The estimated base salary range for this role is $215,000 - $222,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.