Job Description

Job Title: Head, Pharmacovigilance & Medical Affairs

Company Overview:

Pulivarthi Group is a premier global provider of staffing and IT technology solutions, renowned for delivering exceptional services tailored to each client’s unique needs. With a steadfast commitment to excellence, we merge expertise with innovation, ensuring cost-effective solutions of the highest quality. Our diverse client base spans healthcare, finance, government, and beyond, reflecting our adaptability and proficiency across industries. Operating in the United States, Canada, and Mexico, we pride ourselves on aligning with clients' cultures, deploying top-tier talent, and utilizing cutting-edge technologies. Pulivarthi Group stands as a beacon of reliability, efficiency, and innovation in the realm of staffing solutions.

Job Overview/Summary:

Pulivarthi Group is seeking a highly experienced Head of Pharmacovigilance & Medical Affairs to lead drug safety, regulatory compliance, and medical affairs initiatives for North America. This role is responsible for establishing a robust pharmacovigilance quality management system, ensuring 100% compliance with FDA and Health Canada requirements, and aligning medical affairs strategies with corporate and commercial objectives. The ideal candidate will have a strong background in pharmacovigilance operations, regulatory inspections, signal detection, and scientific communication, along with proven leadership in cross-functional collaboration.

Responsibilities:

• Manage, create, and review Individual Case Safety Reports (ICSRs) and Periodic Safety Reports (PSRs) for US and international markets.

• Identify and respond to safety signal analyses and ensure timely submissions to FDA and Health Canada.

• Lead and anchor pharmacovigilance regulatory inspections and audits, ensuring zero critical findings.

• Establish and maintain a comprehensive Pharmacovigilance Quality Management System (QMS) compliant with US regulations.

• Conduct ongoing safety evaluations and benefit-risk assessments for marketed products; oversee Risk Evaluation and Mitigation Strategies (REMS).

• Drive post-inspection corrective and preventive action plans.

• Support and execute North America and Canada Medical Affairs plans aligned with corporate brand strategy.

• Oversee medical information services and ensure seamless integration with pharmacovigilance operations.

• Represent the company at scientific congresses and ensure compliance with pre- and post-meeting reporting standards.

• Lead digital transformation efforts within global pharmacovigilance for efficiency, quality, and 21CFR Part 11 compliance.

• Collaborate effectively with cross-functional teams across regulatory, medical, commercial, and compliance functions.

Primary Skills:

• In-depth understanding of US and Canadian pharmacovigilance regulations, medical information, and medical affairs operations.

• Strong analytical, decision-making, and leadership capabilities.

• Excellent written and verbal communication skills.

• Demonstrated success in managing audits, risk evaluation, and regulatory compliance programs.

• Skilled in project management, stakeholder engagement, and process improvement.

Qualifications:

• Education: Advanced scientific degree (MD, PhD, Pharm.D., or equivalent).

• Experience: Minimum of 10+ years of progressive experience in Pharmacovigilance and Medical Affairs within the pharmaceutical industry.

• Deep understanding of FDA and Health Canada drug development, medical affairs, and pharmacovigilance guidelines.

• Proven ability to lead teams, drive cross-functional collaboration, and implement compliant processes.

• Proficiency in MS Office Suite and familiarity with digital PV systems (GxP, 21CFR Part 11, GAMP 5).

Benefits/Perks:

• Competitive compensation and benefits package.

• Opportunity to lead key pharmacovigilance and medical affairs initiatives in a global setting.

• Collaborative work environment that values innovation and scientific excellence.

Equal Opportunity Statement:

Pulivarthi Group is proud to be an equal opportunity employer. We are committed to building a diverse and inclusive culture and celebrate authenticity. We do not discriminate based on race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, protected veteran status, or any other legally protected characteristics.