Pulivarthi Group (PG)
Head, Pharmacovigilance & Medical Affairs
Pulivarthi Group (PG), Millburn, New Jersey, us, 07041
Head, Pharmacovigilance & Medical Affairs
2 days ago Be among the first 25 applicants
Pay Range Base pay range: $125,000.00/yr - $130,000.00/yr
Follow us on LinkedIn: https://www.linkedin.com/company/pulivarthigroup/
Company Overview Pulivarthi Group LLC is a global staffing and IT technology solutions company dedicated to delivering world‑class solutions. We serve healthcare, financial services, and government entities in the U.S., Canada, and Mexico, combining expertise, innovation, and high‑quality standards to provide cost‑effective, cutting‑edge solutions.
Job Overview/Summary Pulivarthi Group seeks a highly experienced
Head of Pharmacovigilance & Medical Affairs
to lead drug safety, regulatory compliance, and medical affairs initiatives for North America. This role establishes a robust pharmacovigilance quality management system, ensures 100% FDA and Health Canada compliance, and aligns medical affairs strategies with corporate objectives.
Responsibilities
Manage, create, and review Individual Case Safety Reports (ICSRs) and Periodic Safety Reports (PSRs) for U.S. 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 U.S. regulations.
Conduct ongoing safety evaluations and benefit‑risk assessments for marketed products; oversee 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 U.S. 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
Advanced scientific degree (MD, PhD, Pharm.D., or equivalent).
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.
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Pay Range Base pay range: $125,000.00/yr - $130,000.00/yr
Follow us on LinkedIn: https://www.linkedin.com/company/pulivarthigroup/
Company Overview Pulivarthi Group LLC is a global staffing and IT technology solutions company dedicated to delivering world‑class solutions. We serve healthcare, financial services, and government entities in the U.S., Canada, and Mexico, combining expertise, innovation, and high‑quality standards to provide cost‑effective, cutting‑edge solutions.
Job Overview/Summary Pulivarthi Group seeks a highly experienced
Head of Pharmacovigilance & Medical Affairs
to lead drug safety, regulatory compliance, and medical affairs initiatives for North America. This role establishes a robust pharmacovigilance quality management system, ensures 100% FDA and Health Canada compliance, and aligns medical affairs strategies with corporate objectives.
Responsibilities
Manage, create, and review Individual Case Safety Reports (ICSRs) and Periodic Safety Reports (PSRs) for U.S. 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 U.S. regulations.
Conduct ongoing safety evaluations and benefit‑risk assessments for marketed products; oversee 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 U.S. 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
Advanced scientific degree (MD, PhD, Pharm.D., or equivalent).
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.
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