Pharmacovigilance Specialist
1 week ago
Galderma is a leading dermatology company dedicated to advancing the field through innovative products and services. We are seeking a highly skilled Pharmacovigilance Specialist to join our team in Boston, MA.
Job DescriptionThe Pharmacovigilance Specialist will be responsible for managing adverse event records, evaluating incoming communication, and providing medical evaluation of adverse events reports. This role requires a strong understanding of FDA guidelines and regulations, as well as excellent analytical and problem-solving skills.
Key Responsibilities- Evaluate incoming communication for potential adverse event reports and assess their seriousness.
- Provide medical evaluation of adverse events reports and compile pharmacovigilance data.
- Submit expedited reports to FDA and maintain a current working knowledge of company policies and procedures.
- Support internal audits and external inspections, and maintain a current working knowledge of evolving local and international regulations.
- Perform monthly reconciliation activities and maintain a local database of complaint contacts/case tracking & management.
- Provide training to new employees on adverse event collection and reporting.
- Bachelor's degree in a healthcare or science discipline.
- Healthcare education/certifications (i.e. RN, LVN, pharmacist) preferred.
- Two to three years of professional experience in a healthcare setting, pharmaceutical company, or supporting clinical trials.
- Working knowledge of FDA guidelines for post-marketing drug and medical device safety surveillance.
- Excellent analytical and problem-solving skills, with the ability to prioritize and multitask under pressure.
Galderma is an equal opportunity employer dedicated to building an inclusive and diverse workforce. We offer a competitive wage, annual bonus opportunities, and career advancement and cross-training. If you are a motivated and detail-oriented individual with a passion for pharmacovigilance, we encourage you to apply for this exciting opportunity.
-
Quality Assurance Specialist
7 days ago
Boston, Massachusetts, United States PSG Global Solutions Careers Full timeWe're seeking a Quality Assurance Specialist to facilitate the authoring of effective Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs) in a pharmaceutical and medical products industry setting.Key responsibilities include managing the change request, deviation, and periodic review processes of procedural documents. Additionally, the...
-
Boston, Massachusetts, United States BioSpace, Inc. Full timeAbout the RoleWe are seeking an experienced Associate Director, Clinical Quality Compliance to join our team. In this role, you will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and knowledge management.Key ResponsibilitiesProvide...
-
Boston, Massachusetts, United States BioSpace, Inc. Full timeAbout the RoleWe are seeking an experienced Associate Director, Clinical Quality Compliance to join our team. As a key member of our Clinical Quality Compliance function, you will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and...
-
Pharmacovigilance Specialist
4 weeks ago
Boston, United States Galderma Full timeWhether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else. At Galderma, we actively give our teams reasons to believe in our ambition to...
-
Pharmacovigilance Specialist
1 month ago
Boston, United States Galderma Full timeGalderma 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...
-
Pharmacovigilance Specialist
2 weeks ago
Boston, United States Galderma Full timeGalderma 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...
-
Nurse Case Manager
3 weeks ago
Boston, United States Argenx Full timeJoin us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...
-
Nurse Case Manager
3 weeks ago
Boston, United States Argenx Full timeJoin us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...
-
Medical Science Liaison, Cell Therapy- New England
5 months ago
Boston, United States Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
