Pulivarthi Group (PG)
Head Pharmacovigilance & Medical Affairs
Pulivarthi Group (PG), Somerville, New Jersey, us, 08876
Job Overview
Head Pharmacovigilance & Medical Affairs 6 days ago Be among the first 25 applicants Follow us on Linkedin: https://www.linkedin.com/company/pulivarthigroup/ Pulivarthi Group LLC
is a Global Staffing & IT Technology Solutions company, with our prime focus of providing world class solutions to our customers with the right talent. We combine the expertise of our team and the culture of your company to help you with the solution that is affordable and innovative using high quality standards and technologies. We’ve served some of the largest healthcare, financial services, and government entities in the U.S. Job Title:
Head – Pharmacovigilance & Medical Affairs Company Overview Pulivarthi Group is a trusted global provider of staffing and IT technology solutions. With expertise across healthcare, finance, government, and beyond, we deliver tailored workforce solutions to meet diverse client needs. Operating in the United States, Canada, and Mexico, we pride ourselves on aligning with client cultures, deploying top-tier talent, and ensuring compliance with industry standards. Job Summary We are seeking a
Head of Pharmacovigilance & Medical Affairs
to lead and oversee pharmacovigilance operations, regulatory compliance, and medical affairs strategy for North America. The role involves managing drug safety, ensuring regulatory adherence, supporting audits and inspections, and providing medical oversight while aligning with corporate and commercial strategies. Key Responsibilities Manage, create, and review ICSR (US/Foreign) and PSR reports, ensuring timely submission to FDA/Health Canada to maintain 100% compliance with pharmacovigilance regulations. Lead drug safety regulatory inspections in the US, anchor FDA audits, and provide corrective action plans post-inspection. Establish and manage the Pharmacovigilance Quality Management System (QMS) to meet US regulatory requirements. Conduct detailed risk evaluations by comparing current reporting periods with historical data; assess product safety risks and manage REMS programs with regulatory agencies. Support development and execution of North America Medical Affairs and Dr. Reddy’s Canada Medical Affairs plans, aligning with brand and corporate objectives. Oversee medical information services for North America and maintain seamless collaboration with pharmacovigilance service providers. Partner cross-functionally to support scientific congress participation, pre-meeting planning, and post-meeting competitive intelligence reporting. Drive pharmacovigilance digitalization efforts to enhance efficiency, ensure compliance with 21CFR Part 11, GAMP 5, and GxP standards. Qualifications Advanced degree in Life Sciences, Pharmacy, Medicine, or related field (MD, PharmD, PhD preferred). Proven experience in pharmacovigilance, drug safety, and medical affairs leadership roles. In-depth knowledge of US and Canadian regulatory requirements (FDA, Health Canada). Strong experience managing regulatory inspections, audits, and pharmacovigilance compliance. Demonstrated expertise in risk assessment, REMS management, and QMS implementation. Excellent cross-functional collaboration, communication, and leadership skills. Experience with digital transformation initiatives in PV systems preferred. Work Environment Corporate office/remote hybrid with periodic travel for audits, inspections, and conferences. Fast-paced, compliance-driven environment. Benefits Competitive compensation and executive benefits package. Opportunity to lead pharmacovigilance and medical affairs at a strategic level. Career growth in a global healthcare and pharmaceutical environment. Equal Opportunity Statement Pulivarthi Group is an equal opportunity employer committed to creating a diverse and inclusive workplace. We do not discriminate based on race, religion, color, national origin, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status. Seniority level
Mid-Senior level Employment type
Full-time Job function
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Head Pharmacovigilance & Medical Affairs 6 days ago Be among the first 25 applicants Follow us on Linkedin: https://www.linkedin.com/company/pulivarthigroup/ Pulivarthi Group LLC
is a Global Staffing & IT Technology Solutions company, with our prime focus of providing world class solutions to our customers with the right talent. We combine the expertise of our team and the culture of your company to help you with the solution that is affordable and innovative using high quality standards and technologies. We’ve served some of the largest healthcare, financial services, and government entities in the U.S. Job Title:
Head – Pharmacovigilance & Medical Affairs Company Overview Pulivarthi Group is a trusted global provider of staffing and IT technology solutions. With expertise across healthcare, finance, government, and beyond, we deliver tailored workforce solutions to meet diverse client needs. Operating in the United States, Canada, and Mexico, we pride ourselves on aligning with client cultures, deploying top-tier talent, and ensuring compliance with industry standards. Job Summary We are seeking a
Head of Pharmacovigilance & Medical Affairs
to lead and oversee pharmacovigilance operations, regulatory compliance, and medical affairs strategy for North America. The role involves managing drug safety, ensuring regulatory adherence, supporting audits and inspections, and providing medical oversight while aligning with corporate and commercial strategies. Key Responsibilities Manage, create, and review ICSR (US/Foreign) and PSR reports, ensuring timely submission to FDA/Health Canada to maintain 100% compliance with pharmacovigilance regulations. Lead drug safety regulatory inspections in the US, anchor FDA audits, and provide corrective action plans post-inspection. Establish and manage the Pharmacovigilance Quality Management System (QMS) to meet US regulatory requirements. Conduct detailed risk evaluations by comparing current reporting periods with historical data; assess product safety risks and manage REMS programs with regulatory agencies. Support development and execution of North America Medical Affairs and Dr. Reddy’s Canada Medical Affairs plans, aligning with brand and corporate objectives. Oversee medical information services for North America and maintain seamless collaboration with pharmacovigilance service providers. Partner cross-functionally to support scientific congress participation, pre-meeting planning, and post-meeting competitive intelligence reporting. Drive pharmacovigilance digitalization efforts to enhance efficiency, ensure compliance with 21CFR Part 11, GAMP 5, and GxP standards. Qualifications Advanced degree in Life Sciences, Pharmacy, Medicine, or related field (MD, PharmD, PhD preferred). Proven experience in pharmacovigilance, drug safety, and medical affairs leadership roles. In-depth knowledge of US and Canadian regulatory requirements (FDA, Health Canada). Strong experience managing regulatory inspections, audits, and pharmacovigilance compliance. Demonstrated expertise in risk assessment, REMS management, and QMS implementation. Excellent cross-functional collaboration, communication, and leadership skills. Experience with digital transformation initiatives in PV systems preferred. Work Environment Corporate office/remote hybrid with periodic travel for audits, inspections, and conferences. Fast-paced, compliance-driven environment. Benefits Competitive compensation and executive benefits package. Opportunity to lead pharmacovigilance and medical affairs at a strategic level. Career growth in a global healthcare and pharmaceutical environment. Equal Opportunity Statement Pulivarthi Group is an equal opportunity employer committed to creating a diverse and inclusive workplace. We do not discriminate based on race, religion, color, national origin, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries Staffing and Recruiting Referrals increase your chances of interviewing at Pulivarthi Group (PG) by 2x Sign in to set job alerts for “Head of Clinical Research” roles.
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr