Director, Pharmacovigilance

G1 Therapeutics is committed to our mission of improving the lives of people impacted by cancer by developing and commercializing innovative therapies for a variety of tumor types.

We know how a cancer diagnosis affects a person and their family, and we are driven every day to do everything we can to improve outcomes in people who have received the diagnosis.

In addition to driving adoption of our first FDA-approved breakthrough drug for appropriate patients with extensive-stage small cell lung cancer, we are also developing a robust, late-stage clinical pipeline assessing the potential for our medicine in a variety of additional cancers.

Our strategy leverages the experience and drive of the G1 team and our deep experience in inventive and responsible drug development and commercialization.

G1 provides a professional, diverse, inclusive, and creative working environment where individuals can thrive.

We offer an opportunity to bring your best to the team every day, and in doing so, help to save and improve the lives of people living with cancer and their families.

We are driven to succeed by the patient communities we seek to help.

Patients are waiting.

The Opportunity:

G1 Therapeutics is currently recruiting a Director/Senior Director, Pharmacovigilance to join our team in RTP, NC, reporting to the VP, Clinical Development as the company prepares to launch its first product.

This important role will provide broad oversight for pharmacovigilance activities and operations.

To be successful in this role, you must be experienced in the characterization and management of safety risks in both the pre
– and post-approval setting.

You are a proven collaborative leader and self-starter who has the ability to thrive in a matrixed environment, and you have leadership experience in managing safety science and operations teams including contract research organizations.

The Director
– Pharmacovigilance Operations is responsible for overseeing departmental Operations including management of CRO to ensure timely and fully compliant completion of deliverables including, but not limited to, the submission of Periodic Adverse Drug Experience Reports, adverse case exchange with licensing partners, expedited reporting to Health Authorities.

The Director – Pharmacovigilance Operations interfaces with staff or contractors responsible for Safety Systems in implementing a strategy to support the administration and maintenance of the Pharmacovigilance database including data management activities and ad hoc reporting capabilities to meet the clinical safety and post-marketing operational business requirements.

This individual is also responsible for reviewing and monitoring existing performance metrics regarding the exchange of reports with business partners and suggest process improvements as necessary to improve on time reporting.

Responsibilities:

• Acts as the leader in pharmacovigilance activities related to post marketing Pharmacovigilance Operational activities.
• Provides support for clinical safety pharmacovigilance activities including reporting of serious adverse events.
• Manages oversight of CRO to ensure the timely completion and submission of required reports to health authorities and business partners.
• Ensures all adverse event reports made to G1 or contracted safety vendor acting on behalf of G1, are triaged, scheduled, processed and reported according to G1 SOPs and Work Instructions.
• Authors, reviews, and/or approves Policies, SOPs, work instructions, forms and templates for efficient and effective processing of ICSRs and aggregate reports.
• Ensures G1 procedures are in compliance with all ICH-GCP guidelines, Federal Regulations, industry best practice, and agreements with licensing partners and/or regulatory authorities.
• Recommends changes and enhancements to current procedures based on evolving industry regulations and guidelines.
• Identifies, selects and manages relationships with CROs for the PV day-to-day project management and related case-processing activities.
• Reviews G1 PV compliance data to ensure tracking of cases through workflow and on time reporting.
• Participates in identifying trends of PV compliance concerns, identifying business impact of findings, as well as evaluation of adequacy of corrective action to resolve compliance issues.
• Develops and maintains safety data exchange agreements in collaboration with PV Quality Risk Management and manages relationships with partners.
• Collaborates with Pharmacovigilance Team to ensure that medical review and documentation is provided for assigned cases and is in accordance with G1 SOPs and Work Instructions.
• Creates suggestions to protocol development, as well as the development of CRFs and Consent Forms.
• Initiates new safety projects, including the development of study-specific Safety Management Plans, Safety Charters, Reconciliation Plans and other study related documents.
• Supports safety management activities for Investigator Initiated Trials (IITs), including the review and implementation of appropriate safety reporting processes.
• Monitors team productivity, identifies issues, root causes and develops any required resolution plans.
• Undertakes ongoing performance review, feedback and development of staff.

Requirements:

• Knowledge of US and International Regulatory Reporting Requirements for Product Safety, and of the clinical development process
• Experience in Argus safety database configuration validation testing and implementation preferred
• Bachelor’s or advanced degree in health science or related field such as BSN or PharmD.
• Minimum of ten years related progressive experience in a biotechnology or pharmaceutical company including significant pharmacovigilance experience.
• Experience with safety database migration highly desirable
• In depth knowledge of relevant FDA, ICH and GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO DRUG dictionaries.
• Working knowledge of European regulations and regulatory authorities preferred.

Why Join Us?

We know our employees are our most valuable asset, and our culture conveys that.

All employees are issued laptops, and our office staff all have height-adjustable desks, access to a stocked kitchen, and multiple employee events throughout the year.

We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff.

An Equal Opportunity Employer

G1 Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.

All employment decisions at G1 Therapeutics are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.