No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease.
For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them.
The Associate, Case Processing GPV-US is responsible for the collection, assessment and processing of adverse events and product complaints for Pre- and Post-Marketed products to ensure compliance with worldwide reporting regulations.
- Collects, assesses and processes adverse events for Pre- and Post-Marketed products to ensure compliance with worldwide regulations and guidelines.
- Processes adverse event reports from initial case receipt through case completion, including phone coverage for the Safety Phone.
- Assists in processing of Product Inquiry Reports relating to Lundbeck products from consumers and healthcare professionals.
- Defines, initiates and tracks follow-up information/correspondence through to case closure.
- Participates in triaging of safety reports for regulatory reporting purposes, including the assignment of causality and labeledness for adverse events.
- Participates in communication with clinical, safety and medical affairs teams for individual clinical trial and post-marketed adverse event reports.
- Initiates MedDRA coding of adverse events in the safety database.
- Maintains communication with Lundbeck global partners to ensure prompt notification of safety issues.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
- Accredited Bachelor’s Degree, BSN or MSN or PharmD or MPharm.
- 1+ year of experience with post-marketing and/or clinical safety reporting requirements in a biotech or pharmaceutical company.
- Working knowledge of Global regulations/guidelines and requirements with regard to safety information in the pharmaceutical industry, which includes legal and regulatory requirements.
- Excellent computer skills.
- Demonstrated interpersonal skills and ability to deal effectively and tactfully with providers of adverse event information.
- Demonstrated ability to work well in a fast paced environment.
- Excellent organizational, written and verbal skills.
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- Willingness/Ability to travel up to 5% domestically. International may be required.