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Lupin Pharmaceuticals · 6 hours ago

Sr. Specialist/Manager, Pharmacovigilance

Somerset, NJ

Full-time

Onsite

Mid, Senior Level

$90K/yr - $150K/yr

4+ years exp

Lupin Pharmaceuticals is a fast growing and innovative company focused on manufacturing, research and development, and commercial divisions. The Pharmacovigilance Sr. Specialist position involves overseeing pharmacovigilance operations and ensuring compliance with US and Canadian regulatory requirements, supporting risk management and drug safety standards.

BiotechnologyPharmaceuticalRobotics

H1B Sponsor Likely

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

Qualification

PharmDPharmacovigilance experienceProblem-solving skillsWritten communicationOral communicationProactive behaviorAccountabilityStrategic thinkingCollaboration

Required

Must have a PharmD or Physician Assistant or Nurse Practitioner with 4+ 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

Benefits

Discretionary performance bonus (based upon eligibility)

Company

Lupin Pharmaceuticals

Lupin Pharmaceuticals is a generic pharmaceutical company.

Founded in 2003

Baltimore, Maryland, USA

501-1000 employees

http://www.lupinpharmaceuticals.com

H1B Sponsorship

Lupin Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (6)

2023 (2)

2022 (8)

2021 (6)

2020 (4)