Head of Pharmacovigilance

Overview

Corteria Pharmaceuticals is a privately held company that develops first-in-class drugs in subpopulations of heart failure. Our strategy involves innovative stratification of patients and selection of our targets based human validation. We use state-of-the-art methods to stratify patients and identify those who will benefit most from our treatments. Our programs aim to treat well defined heart failure subpopulations (worsening heart failure, acute heart failure with hyponatremia, right heart failure) and obesity with co-morbidities.

We develop several candidates around clinically validated targets CRF2 and vasopressin

• CRF2 projects: endogenous CRF2 ligands (urocortin 2 or stresscopin) have been validated in heart failure patients but their very short half-life which makes them unsuitable for subchronic use. Our strategy is to develop a potent, selective, long-acting CRF2 agonist suitable for subcutaneous administration for the treatment of worsening heart failure.
• Vasopressin project: therapeutic targeting of vasopressin requires the blockade of its 3 receptors (V1a, V1b, V2) which cannot be achieved today by a small molecule approach. To overcome this issue we are developing a neutralizing human monoclonal antibody directed against vasopressin.

Responsibilities

• Ensure high-quality, accurate and timely medical contributions to the safety evaluation of Corteria compounds
• Work closely with the PV team of the CRO, the CRO’s medical monitor and Corteria’s CRD by attending the medical monitoring meetings and leading signal detection activities using data from all sources
• Support the drafting, review and validation of clinical study case narratives/CIOMS/PV safety reports for inclusion in study reports and submission to DSMB and Regulatory Authorities and ECs/IRBs, as required
• Support the drafting, review and finalization of the DSURs for all Corteria’s compounds in clinical development
• Participate in periodic reviews to ensure quality control of data entry, MedDRA coding, and narrative writing
• Develop and implement department policies and procedures to achieve department and corporate goals
• Respond to case-related emails and inquiries from external service providers
• Monitor case processing timelines, investigate any delays in reporting or transmission, and draft/validate the deviation forms (root cause, CAPA) for cases submitted late to Regulatory authorities
• Contribute to the reconciliation of PV cases with business partners per Safety Management Plans (SDEAs)
• Review the protocol and the Safety Management Plan for all Corteria’s clinical trials
• Contribute to the preparation of Benefit Risk Assessments for Corteria compounds and provide appropriate support for implementation of the associated conclusions
• Develop appropriate risk management strategies for Corteria compounds ensuring that these are contained and implemented in appropriate way including Risk Management Plans
• Contribute to the preparation and review of pharmacovigilance documentation for internal and external use by providing medical expertise to the preparation of responses to internal and external questions relating to the safe use of Corteria products
• Ensure that updated safety profiles of Corteria products are provided to senior management as required
• Represent Pharmacovigilance at internal and external meetings where issues of drug safety are to be, or may be, discussed
• Maintain awareness of changes to regulatory guidance documents, requirements and state-of-the-art pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness and profile of the PV activities
• Work cross functionally within Corteria members to meet Company objectives and to represent the Pharmacovigilance in a team-oriented manner and delivering quality and timely input to meet the needs of the projects
• Set high standards on deliverables while managing risks and timelines

Education and Experience

• MD degree is required.
• Minimum 5 - 10 years’ experience in pharmacovigilance case management within an international environment.
• Knowledge of regulatory requirements pertaining to pharmacovigilance in the pre-approval environment.
• Excellent command of GXPs (i.e. GCPs, GMPs, and GLPs).
• Ability to interact with and present to various internal and external audiences; like DSMB, leadership team, project teams and other internal/external forums.
• Fluent in English
• Excellent writing skills as they relate to preparation of safety and regulatory documents.
• Excellent interpersonal skills with strong oral/written communication and presentation skills.
• Excellent problem-solving ability.
• Excellent leadership skills.
• Demonstration of cross-functional understanding related to drug development.
• Good judge of risks and a keen ability to analyze options and manage outcomes.
• Experience in the use and management of Drug Safety Databases and MedDRA coding. Skilled in Microsoft Office applications (Word, PowerPoint and Excel).

Preferred

• Experience in cardiovascular and metabolism programs is preferred.
• Prior experience working at a small company with wide ranging related responsibilities is preferred.
• Prior experience in other drug development functions (e.g., Regulatory, Nonclinical and Clinical) is preferred.

Work setting

• Hybrid.
• Candidates who reside in the Paris area will be expected to spend at least 2 days/week at the Company’s office in Massy, France.