gerente farmacovigilancia

Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What's more, we're achieving it in a company that we're in control of. In an environment that we're co-creating. And a culture that's uniquely ours. Care to join us. It isn't a question.

Key Responsibilities:

• Serve a Haleon PV Ops (Pharmacovigilance Operations), Single Case Processing global safety database SME contributing to the development, implementation, launch and maintenance of the global safety database with critical attention to the program's success, while ensuring global case management activities align with Haleon standards for PV processing;

• Generate PV Ops (Pharmacovigilance Operations), SCP (Single case processing) operative policies, procedures, trainings and relevant instructional materials for the global safety database worldwide users in compliance with worldwide regulations and industry standards to safeguard against inspection findings;

• Deputize the Senior Manager Pharmacovigilance Single Case Processing, Knowledge Center in case of an inspection or partner audit;

• Support the development and continuous improvement of the global safety database as workstream content contributor and support backlog grooming sessions, iterative review of requirements (user stories, data requirements, mappings and other decisions relevant to PV SCP (Pharmacovigilance Single Case Processing);

• Assess training delivery needs and develop training storyboards that will be created and uploaded to the learning management system by Quality and Document Control;

• Identify target training audiences applicable to procedural documents and mapped to training curriculum;

• Create processes that ensures quality and compliant oversight with case management PV processes and regulatory submission activities for HSI from all sources worldwide in order to meet regulatory compliance with authorities and PV standards, including but not limited to CIOMS, ICH, GVP, FDA, EMA, MHRA, PMDA;

• Lead cross-functional training of relevant stakeholders;

• Participate in special projects as assigned.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in a scientific or medically related field;

• Solid knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements, clinical safety documentation, local regulatory requirements, and pharmacovigilance methodology; understanding of world-wide pharmacovigilance regulatory requirements; other consumer health areas nutritionals, cosmetics and devices a plus;

• Demonstrated pharmacovigilance/clinical safety or related experience;

• Direct experience working with outsourced providers;

• Demonstrated project management skills and prioritize competing priorities;

• Knowledge of principles of data collection, manipulation and retrieval;

• Knowledge of principles of data collection, manipulation and retrieval and experience summarizing data;

• In-depth understanding of medical and drug terminology and coding (MedDRA, IMDRF, etc.).

If you feel this is your next career step, apply by 11/08/2022

Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Care to join us. Find out what life at Haleon is really like

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific accommodations you are requesting. We'll provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.