Contract Drug Safety Associate Details

Contract Drug Safety Associate

Lupin Pharmaceuticals Inc. - Somerset, NJ

Employment Type : Full-Time

Overview: Lupin U.S. is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and Commercial divisions. Somerset, New Jersey is home to one of eighteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin. Somerset, New Jersey is also the location for Lupin’s U.S. Sales Operations and Marketing divisions, as well as internal Product Development teams.
Lupin has a significant generic pipeline and a growing Specialty Brand presence in the U.S. Our Inhalation Research and Development facility is located in Coral Springs, Florida focusing on generic and branded orally inhaled and nasal drug products. Key shared service functions are found at our harbor side location in Baltimore, Maryland. Adding to Lupin’s U.S. footprint is a robust team of Clinical Operations experts in Blue Bell, Pennsylvania and a high performing Specialty salesforce located across the country.
Lupin is prided on being people-focused and centered around how impactful we are with our customers. Join our U.S. team and become part of an organization that encourages professional development and innovation! We are looking for passionate and driven individuals who will help us to continue making medicine widely accessible to patients, and who strive to work by Lupin’s Core Values of Teamwork, Passion for Excellence, Entrepreneurial Spirit, Respect and Care, Integrity, and Customer Focus. Responsibilities: Role and Responsibilities
The Contract Drug Safety Assocaite will support the Associate Director Pharmacovigilance and REMS on a part-time bases Monday- Friday 25 Hours Per week. conducting the following tasks:

• Receipt, acknowledge, and communicate all adverse event reports received through mail from reporters and other manufacturers and vice versa.
• Maintain and share log on receipt of all adverse event reports with reconciliation team
• Prepare weekly report on the adverse event reports received through mail and fax from all sources (reporters, manufacturers)
• Performing triage of mails addressed to US pharmacovigilance team but not limited to Adverse events, Product Complaints and Medical information
• Escalate urgent safety related information to reporting manager and DSRM team
• Coordinate and support REMS coordinator on delegated sponsor activities in enrolled REMS program
• Support in conducting pharmacovigilance training for New Hires
• Maintaining pharmacovigilance training logs and ensuring all company employees are trained
• Support in maintaining pharmacovigilance SOPs in the North America

Qualifications: Qualifications and Education Requirements

• Life science background. Pharmacists and nurses preferred. Bachelors or masters’ degree in science at an accredited university.
• Excellent communication skills, including the ability to speak clearly, listen and gain clarification, respond well to questions, and write clearly and informatively.
• Able to work as part of team and adapt to changes in work duties
• Detail-oriented, thorough and methodical, and able to follow timeline

Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Work is performed in an office environment.
COVID19 Vaccination Requirements:
If you are hired, Lupin will require you to prove that you are fully vaccinated against COVID-19, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents you from becoming vaccinated. As an employee, you will be required to follow Lupin policies related to any additional or future COVID-19 vaccination or booster shot requirements.