Associate Director/Director, Pharmacovigilance Operations

4 weeks ago

Remote, Oregon, United States Cogent Biosciences Full time

Who We Are

Cogent Biosciences is a biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent's lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has already exhibited promising early clinical activity and safety in a Phase 1/2 trial in patients with advanced GIST and also has the potential to fill an unmet need for patients living with Systemic Mastocytosis.

Our Offer To You

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, and a 401(k) plan.

We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.

Position Overview:

As AD/Director of Pharmacovigilance Operations, you will provide strategic and operational PV support for Cogent's development products. In this role you will be tasked with standardizing the approach to global clinical trial and future post marketing PV operations across our therapeutic areas so that we can consistently produce quality and timely deliverables.

Core responsibilities

· Oversight of the PV operational and case management activities for safety reporting including the collection, processing, and reporting/submission of safety information.

· Generate performance and compliance metrics and monitor trends.

· Collaborate with study team members to develop documents related to safety case processing and reporting (e.g., Safety Management Plan, reconciliation plan, SAE report form and completion guidelines, and all safety vendor documents).

· Provide Safety Operational support to clinical trial study teams as needed.

· Develop and maintain Safety Data Exchange Agreements (SDEAs) and PV agreements with partners, vendors, and other third parties.

· Collaborate within PVRM and other internal teams to prepare for Regulatory Authority inspections and in relevant internal/external audits.

· Ability to transition processes and create new infrastructure into a post marketing landscape, when applicable.

· Work with senior leaders throughout Cogent to establish and/or optimize a strategy for organizational build, process improvement initiatives and operational efficiency as our product portfolio grows.

· Serve as a subject matter expert for internal audits and global regulatory inspections.

About You:

· Minimum of a Bachelor's Degree preferably in a scientific field, Healthcare professional degree preferred (PharmD, RPh, RN, NP, PA).

· Minimum 8 years PV experience, 2-3 years of management experience preferred

· Minimum of 4 years managing PV vendors.

· Expertise in Argus or other safety databases.

· Experience with internal audits and global regulatory inspections.

· Ability to establish and/or identify best practices for continuous improvement of case quality, compliance, and process improvements.

· Demonstrate the ability to handle increasing responsibilities as scope of responsibilities may change (team growth, integration efforts across other department organizations).

· Ability to help shape key department goals and objectives and drive process and operational efficiencies.

· Able to work independently, establish work priorities, and execute decisions with minimal guidance.

· Provide advice and support to other internal departments with respect to drug safety standards and requirements.

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