Associate Director, Pharmacovigilance and Local Safety Officer (LSO)

Job title:

Associate Director, Pharmacovigilance and Local Safety Officer (LSO)

Company

Pierre Fabre

Job description

Your missionAssociate Director, Pharmacovigilance and Local Safety Officer (LSO)At Pierre Fabre Pharmaceuticals Inc. our mission is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better. We are the US pharmaceutical subsidiary of Pierre Fabre Laboratories Worldwide, a foundation-owned company with 7 decades of impact. Pierre Fabre Laboratories is a truly global healthcare company, established in 43 countries, with products distributed in 119 territories across the globe. Pierre Fabre’s foundation ownership enhances our ability to focus on creating long-term value for patients.Building on the legacy of Pierre Fabre Laboratories, innovation is our life blood and patient experience drives everything we do. We aspire to design and develop therapeutic solutions inspired by patients and healthcare professionals; draw on science and nature as perpetual sources of inspiration; develop long-term partnerships with researchers and innovators worldwide; and place pharmaceutical ethics and climate transition at the heart of our action.Pierre Fabre Pharmaceuticals is headquartered in Parsippany, NJ alongside Pierre Fabre USA Inc., a Pierre Fabre Laboratories subsidiary focused on dermatology and cosmetics.SUMMARY:Pierre Fabre is a large private French multinational pharmaceutical and cosmetics company building a new US oncology division. We are looking for creative, highly motivated individuals to help prepare for the successful launch of potentially the first allogeneic T-cell immunotherapy approved in the US (“Therapy”). Patients with a history of bone marrow or solid organ transplant can suffer from this rare, often deadly lymphoma, which currently has no approved FDA therapies. Pierre Fabre Pharmaceuticals in the US currently markets HEMANGEOL® (propranolol hydrochloride) oral solution indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.The Associate Director, Pharmacovigilance and Local Safety Officer (LSO) will lead the Pharmacovigilance organization and implement the US safety process for the Pierre Fabre Pharmaceutical US product portfolio. This position will act as the Local Safety Officer partnering with the Pierre Fabre global organization. This is an exciting opportunity to be part of an organization that is preparing to launch a new class of advanced therapeutics while making a meaningful impact in the lives of patients with a life-threatening disease.ESSENTIAL FUNCTIONS:Internal & External US Safety Expert

• Provide PV and risk management expertise to internal and external customers.
• Safety expert for Pierre Fabre Pharmaceuticals US products.
• Maintain knowledge of product, product environment, and recent literature
• Maintain US PV expertise and understanding of international safety regulations and guidelines.
• Lead cross functional Safety Management Teams (SMTs).
• Communicate with and represent PV analyses and PV position within project/product teams, in safety governance and benefit-risk governance activities and committees (e.g. Safety Management Committee, Benefit-Risk Assessment Committee), with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations.
• Provide strategic and proactive safety input into development plans.
• Support due diligence activities and pharmacovigilance agreements.

Signal Detection & Assessment

• Responsible for signal detection and analysis.
• Collaborate with the Global Pierre Fabre organization for signal detection, data mining, and safety epidemiology assessments.
• Identify and implement proactive safety analysis strategies to further define the safety profile.
• Lead aggregate safety data review activities and coordinate safety surveillance activities.

Risk Assessment & Risk Management & Benefit-Risk Assessment

• Provide proactive risk assessment.
• Co-lead benefit-risk assessment with other relevant functions.
• Develop risk management strategies and plans and monitor effectiveness.

Submission Activities

• Represent safety position in cross functional submission teams.
• Ensure generation, consistency, and quality of safety sections in submission documents.
• Write responses or contributions to health authorities’ questions.

Report Authoring

• Document, contribute to, coordinate, review and/or validate Periodic Reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report.
• Serve as the US safety expert to the Global PV Periodic Reports group for assigned projects and products.
• Lead internal and external resources supporting the Pharmacovigilance activities.

REQUIRED EDUCATION AND EXPERIENCE:

• 8+ years of biotech/pharma required with 6+ years’ experience in Pharmacovigilance.
• M.D. degree. Bachelor’s degree and post graduate degree.
• For M.D., minimum 3 years’ and for other degrees, minimum 6 years’ experience in PV
• Extensive experience participating in cross-functional projects and teams.
• Rare diseases and/or oncology experience is highly desirable.
• Experience with biologics; cell or gene therapy experience is highly desirable.
• Scientific curiosity, creativity, and flexibility
• Ability to thrive in a fast-paced startup environment with high expectations.
• Ability to appropriately access and handle business information in compliance with all applicable laws, regulations and / or Pierre Fabre policies.
• A passion for making a difference in the lives of patients.

WORK ENVIRONMENT:

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

LOCATION: US, remoteBenefits of being a Pierre Fabre EmployeeJoin Pierre Fabre for competitive benefits including three medical plans, dental and vision coverage, voluntary benefits, a 401(k) plan, and more! Our offerings also include a hybrid work policy, a generous PTO policy and company holidays, paid parental leave, discounts on our products, learning and development opportunities, and access to mental health and wellness programs, creating a well-rounded work experience for our employees.Pierre FabrePierre Fabre has been recognized by Forbes as one of the “World’s Best Employers” for the 3rd year running.Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.Who you are ?We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.

Expected salary

Location

USA

Job date

Wed, 16 Oct 2024 07:25:25 GMT

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