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.

Role and Responsibilities

We are seeking a talented and motivated healthcare professional with some experience in pharmacovigilance to join our team. As an Drug Safety Associate, you will support our Pharmacovigilance group with a focus on operational execution of pharmacovigilance matters for our products in the US and Canada.

• Accountable for receipt, acknowledgement and communication of all adverse events reports received through mail from reporters and other manufacturers and vice versa.
• Performing triage of mails addressed to US pharmacovigilance team including but not limited to Adverse events, Product Complaints and Medical Information.
• 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).
• Accountable for ensuring Pharmacovigilance Trainings are undertaken, conducted and compliance is achieved.
• Accountable for evaluating pharmacovigilance training logs as applicable and ensuring all company employees and vendors are trained.
• Accountable for conducting and ensuring test calls and test fax are conducted on all Lupin toll free numbers in line with the SOPs.
• Support the North America PV lead in ensuring PV compliance in line with the DSRM SOPs.
• Partner with Global DSRM SDEA team, 3^rd party business units to ensure timely review and execution of Safety data exchange agreements.
• Author or support in review of pharmacovigilance SOPs in the North America (United States and Canada) as required.
• Partner with Global DSRM safety writing team and engage in development of risk management plans, additional risk minimization activities, implementation of RMPs and aRMMs for Canada as required
• Provide support, participation as required, maintain documentation, review and inputs on the safety aspects of REMS programs in the US to the North America PV lead.
• Escalate drug safety related information to North America PV lead.
• Support in routine pharmacovigilance activities as and when required.

Qualification Requirements / Education

• BA/BS in life sciences, M.S, R.N, Pharm D or similar preferred.

Qualification Requirements / Experience and Skills

• Detailed knowledge of PV regulations, and post-marketing obligations
• Adept at navigating in a sophisticated matrix environment spanning across various geographies to accomplish objectives with teamwork.
• Excellent oral and written communications skills interpersonal, problem solving - English is required.
• Detail-oriented, thorough, methodical, and able to follow the timelines.