Pharmacovigilance Specialist

1 month ago

Boston, United States Galderma Full time
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare 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 are 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: Pharmacovigilance Specialist

Location: Boston, MA (Hybrid 3 days in office)

Job Description

The Pharmacovigilance Specialist is responsible for day-to-day case management of adverse event records. This position assesses incoming communication to identify potential adverse event reports. The Pharmacovigilance Specialist provides medical evaluation of adverse events reports, compiles pharmacovigilance data, and analyzes and submits expedited to FDA. The adverse event handling accountabilities reflect activities required to comply with local and international regulations, guidelines and applicable directives.

Key Responsibilities
Evaluates incoming communication for potential adverse event reports via local intake system, phone, fax, mail and other methods.
Medically evaluates adverse event reports for possibility of seriousness and expedited reporting to FDA
Performs/coordinates follow up activities to obtain missing and additional information required for case processing
Compiles, evaluates and submits serious and periodic reports to FDA.
Ensures receipt of adverse events from marketing programs, license partners and social media platforms
Performs monthly reconciliation activities
Supports internal audits and external inspections
Maintains a current working knowledge of:
Company policies and procedures, departmental processes and associated work instructions
Evolving local and international regulations, guidelines and applicable directives
Galderma products (product inserts, DFUs, Promotional materials)
Maintains and verifies local database of complaint contacts/case tracking & management
Performs reconciliation with Medical Information, Product Quality and License partner
Provides training to new employees about adverse event collection and reporting including training to call center vendor.
Other duties as assigned.

Skills & Qualifications
Bachelor’s degree, preferably in healthcare or science discipline, is required
Healthcare education/certifications (i.e. RN, LVN, pharmacist) preferred
Two (2) to Three(3) or more years of professional experience in a healthcare setting, pharmaceutical company or supporting clinical trials, required
Working knowledge of FDA guidelines for post-marketing drug and medical device safety surveillance
Working knowledge of medical terminology, medical conditions, chemical structures/biological systems and drug products x Familiar with relevant computer software such as ARGUS or similar Drug Safety database
Ability to prioritize, problem solve, think critically and multi-task under pressure is required
Proficiency in MS Office including Word, Excel, PowerPoint, and Outlook
Good written and verbal communication skills
Strong organizational skills x Ability to work independently as well as with a team to accomplish tasks
Boston Hybrid Role - 3 days/week in office

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.

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