Senior Pharmacovigilance Specialist - Dallas, United States - N/A

Description

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Job Title: Senior Pharmacovigilance Specialist

Location
: Dallas, TX preferred (hybrid position)

Job Description

The Senior PV Specialist position is integral to the organization in order to maintain compliance in accordance with regulations and laws established by local and global Health Authorities. Responsible to ensure evaluation of adverse events reported from health care providers, literature, company representatives and consumers for all Galderma products. Participates in the quality management system in Pharmacovigilance to ensure that the department standards are met (training requirements, implementation of continuous improvement actions) Company regulatory compliance is dependent on the role of the Senior PV Specialist. Acts as the Deputy Local Safety Officer (LSO).

Key Responsibilities

• Implement Pharmacovigilance & Quality plans, processes and policies while supporting the activities of collecting adverse event data on all marketed and in development products and determining quality of R&D studies in accordance with Good Laboratory Practices (GLP) and local and international regulations
• Implement adverse event processes and databases
• Align and implement Pharmacovigilance & Quality plans to provide integrated strategic safety expertise to clinical development programs
• Reconcile and process high-quality product safety data and analysis to internal and external customers throughout the product life cycle
• Implement and execute programs and policies of pharmacovigilance with rapid identification and analysis of safety signals to define emerging drug safety profiles of all products and drive patient risk management
• Administer all activities to control the quality and accuracy of the data used in drug discovery and preclinical development programs
• Participate in quality audit programs and ensure their implementation

Skills & Qualifications

• Bachelor's Degree Preferred
• Registered Nurse license Required
• At least 3-4 years' experience in cosmetovigilance, pharmacovigilance or device vigilance is required.
• Advanced knowledge of FDA guidelines for post-marketing drug safety surveillance.
• Advanced knowledge of medical terminology, medical conditions, chemical structures/biological systems and drug products
• Advanced proficiency in use of Arisg or similar Drug Safety database.

What we offer in return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.

Next Steps

• If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager
• The final step is a panel conversation with the extended team

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Employer's Rights:

Galderma is an equal opportunity employer dedicated to building an inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, genetic information, or any other characteristic protected by applicable law. Galderma is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment.