Head â Pharmacovigilance & Medical Affairs
Head â Pharmacovigilance & Medical Affairs
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Job Description
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:
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Manage create and review ICSR (US/Foreign) and PSR reports ensuring timely submission to FDA/Health Canada to maintain 100% compliance with pharmacovigilance regulations.
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Lead drug safety regulatory inspections in the US anchor FDA audits and provide corrective action plans post-inspection.
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Establish and manage the Pharmacovigilance Quality Management System (QMS) to meet US regulatory requirements.
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Conduct detailed risk evaluations by comparing current reporting periods with historical data; assess product safety risks and manage REMS programs with regulatory agencies.
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Support development and execution of North America Medical Affairs and Dr. Reddys Canada Medical Affairs plans aligning with brand and corporate objectives.
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Oversee medical information services for North America and maintain seamless collaboration with pharmacovigilance service providers.
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Partner cross-functionally to support scientific congress participation pre-meeting planning and post-meeting competitive intelligence reporting.
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Drive pharmacovigilance digitalization efforts to enhance efficiency ensure compliance with 21CFR Part 11 GAMP 5 and GxP standards.
Qualifications:
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Advanced degree in Life Sciences Pharmacy Medicine or related field (MD PharmD PhD preferred).
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Proven experience in pharmacovigilance drug safety and medical affairs leadership roles.
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In-depth knowledge of US and Canadian regulatory requirements (FDA Health Canada).
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Strong experience managing regulatory inspections audits and pharmacovigilance compliance.
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Demonstrated expertise in risk assessment REMS management and QMS implementation.
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Excellent cross-functional collaboration communication and leadership skills.
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Experience with digital transformation initiatives in PV systems preferred.
Work Environment:
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Corporate office/remote hybrid with periodic travel for audits inspections and conferences.
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Fast-paced compliance-driven environment.
Benefits:
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Competitive compensation and executive benefits package.
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Opportunity to lead pharmacovigilance and medical affairs at a strategic level.
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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.
Employment Type
Full-time
