Job Description

Overview
Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

Responsibilities
We are seeking an experienced, talented and motivated healthcare professional with some experience in pharmacovigilance to join our team. The Pharmacovigilance Sr. Specialist position at Lupin’s Somerset, NJ office involves overseeing pharmacovigilance operations and ensuring compliance with US and Canadian regulatory requirements. The role supports risk management and REMS programs, safety data review, and collaboration with various departments to maintain drug safety standards.

Essential Duties and Responsibilities

Strategically oversee PV compliance with relevant regulations and internal SOPs.
Serve as liaison between the PV team and cross-functional stakeholders.
Direct and monitor the collection, evaluation, and reporting of safety data for company products.
Implement and optimize PV processes to enhance efficiency and regulatory compliance.
Represent the PV function during internal and external audits or inspections.
Develop risk management strategies, ensure implementation of Risk Management plans in Canada
Ensure build, development and implementation of REMS in US.
Collaborate with global PV teams to harmonize safety practices and share best practices.
Analyze safety data trends and escalate potential risks to senior leadership.
Drive continuous improvement initiatives to advance PV operational excellence.
Contribute to the creation and revision of SOPs and work instructions relevant to PV operations
Conduct and monitor PV training for all employees and vendors to ensure up-to-date knowledge of pharmacovigilance practices and regulatory requirements.
Report to the Director of Pharmacovigilance and REMS, providing regular updates on PV and Risk Management performance and compliance.
Other PV and Risk Management duties as assigned
Qualifications
Required Qualifications:

Must have a PharmD or Physician Assistant or Nurse Practitioner with 3+ years of relevant experience in Pharmacovigilance (PV).
Strong problem-solving skills, particularly in enforcing safety rules and global procedures as outlined in SOPs, working instructions, Operational Manuals, and Guidance documents.
Excellent written and oral communication skills, including fluency in English.
Demonstrates proactive behavior and the ability to adhere to timelines.
High degree of responsibility and accountability.
Ability to develop cooperative working relationships with all levels of staff across all geographies is critical.
Demonstrates strategic thinking.
Collaborates with accountability.
Acts, learns quickly, and continually develops by applying new learnings promptly.

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