BioSpace
Vice President, Global Patient Safety Operations
BioSpace, Tarrytown, New York, United States, 10591
Vice President, Global Patient Safety Operations Join to apply for the
Vice President, Global Patient Safety Operations
role at
BioSpace Vice President, Global Patient Safety Operations 21 hours ago Be among the first 25 applicants Join to apply for the
Vice President, Global Patient Safety Operations
role at
BioSpace Get AI-powered advice on this job and more exclusive features. The Vice President (VP) of GPS Operations is responsible for overseeing the global pharmacovigilance areas of Case Evaluation and Reporting (CER), Quality and Compliance Center of Excellence (CoE) ensuring the effective operations and compliance across our portfolio lifecycle and geographies.
Remember to check your CV before applying Also, ensure you read through all the requirements related to this role.
This executive role requires a strategic business leader with experience in leading patient safety areas, proven abilities with team development, in depth understanding of pharmacovigilance operations, quality and compliance, planning, and assessing and implementing regulatory requirements, along with shown capabilities to lead cross-functional initiatives. The VP of GPS Operations will drive operational excellence, compliance, and continuous improvement of globalization and innovation of PV capabilities, operations, and compliance. This leader will develop a leadership team, provide team oversight of talent development, and join the GPS Leadership Team (LT).
A typical day as a Vice President, Patient Safety Operations might look like:
This leadership position is responsible for all aspects of pharmacovigilance operations and delivery in support of team areas of GPS:
CER (Case Evaluation and Reporting) Q&C CoE (Quality and Compliance Center of Excellence)
This role requires an ability to provide strategic business leadership and direction to the pharmacovigilance team, fostering a culture of excellence, efficiency, compliance, and continuous improvement, and strengthening inspection readiness. This role collaborates with executive leadership to integrate pharmacovigilance strategies with broader company objectives and applicable initiatives on behalf Regenerons portfolio and regulatory requirements. Provide pharmacovigilance leadership, expertise and guidance to cross-functional teams to support product development, regulatory submissions, and post-marketing activities in the areas of case operations, PV quality and compliance and planning. Deliver business excellence to improve efficiencies, optimize resource utilization, and strategic oversight of safety systems. Oversee and manage all aspects of pharmacovigilance activities, including adverse event reporting, signal detection, risk management, and benefit-risk assessments. Ensure timely and accurate submission of safety reports to regulatory authorities and maintain compliance with global pharmacovigilance regulations. Develop forecasting methods and critical methods to optimize vendors and third-party partners to deliver efficiencies. Implement and manage robust pharmacovigilance systems and processes to ensure the highest standards of data integrity and quality. Keep abreast of global regulatory requirements, including providing assessments to the GPS LT and working in partnership with the QPPV Office to ensure compliance with all relevant pharmacovigilance regulations and guidelines. Strengthen all aspects of pharmacovigilance for readiness and inspections and audits. From an operations perspective, meets stakeholder needs including but not limited to Global Development, IOPS (Industrial Operations and Product Supply), Commercial, and Business Development. Collaborate with all areas of GPS: Safety Sciences, Pharmacoepidemiology and Risk Management CoE, QPPV office, etc. along with Regeneron areas including GD quality, vendor management, medical affairs, regulatory affairs, and other relevant departments to ensure seamless integration of pharmacovigilance activities and objectives. Provide PV expertise and mentorship to cross-functional teams to support product development, regulatory submissions, and post-marketing activities. Establish and ensure department Key Performance Indicators (KPIs) and PV vendor metrics.
This Role Might Be For You If
Advanced degree in life sciences, pharmacy, medicine, or a related field (MD, PharmD, PhD preferred). Minimum of 20 years of experience in pharmacovigilance within the biotech or pharmaceutical industry. Extensive knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH). Proven track record of leadership and strategic management, team development in pharmacovigilance. Strong understanding of drug development processes and post-marketing surveillance. Excellent communication, interpersonal, and organizational skills. Ability to work collaboratively in a fast-paced, dynamic environment.Strong business acumen and proven ability to collaborate across all organizational levels.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$300,000.00 - $500,000.00Seniority level
Seniority levelExecutive Employment type
Employment typeFull-time Job function
Job functionBusiness Development and Sales IndustriesInternet News Referrals increase your chances of interviewing at BioSpace by 2x Get notified about new Vice President of Global Operations jobs in
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Vice President, Global Patient Safety Operations
role at
BioSpace Vice President, Global Patient Safety Operations 21 hours ago Be among the first 25 applicants Join to apply for the
Vice President, Global Patient Safety Operations
role at
BioSpace Get AI-powered advice on this job and more exclusive features. The Vice President (VP) of GPS Operations is responsible for overseeing the global pharmacovigilance areas of Case Evaluation and Reporting (CER), Quality and Compliance Center of Excellence (CoE) ensuring the effective operations and compliance across our portfolio lifecycle and geographies.
Remember to check your CV before applying Also, ensure you read through all the requirements related to this role.
This executive role requires a strategic business leader with experience in leading patient safety areas, proven abilities with team development, in depth understanding of pharmacovigilance operations, quality and compliance, planning, and assessing and implementing regulatory requirements, along with shown capabilities to lead cross-functional initiatives. The VP of GPS Operations will drive operational excellence, compliance, and continuous improvement of globalization and innovation of PV capabilities, operations, and compliance. This leader will develop a leadership team, provide team oversight of talent development, and join the GPS Leadership Team (LT).
A typical day as a Vice President, Patient Safety Operations might look like:
This leadership position is responsible for all aspects of pharmacovigilance operations and delivery in support of team areas of GPS:
CER (Case Evaluation and Reporting) Q&C CoE (Quality and Compliance Center of Excellence)
This role requires an ability to provide strategic business leadership and direction to the pharmacovigilance team, fostering a culture of excellence, efficiency, compliance, and continuous improvement, and strengthening inspection readiness. This role collaborates with executive leadership to integrate pharmacovigilance strategies with broader company objectives and applicable initiatives on behalf Regenerons portfolio and regulatory requirements. Provide pharmacovigilance leadership, expertise and guidance to cross-functional teams to support product development, regulatory submissions, and post-marketing activities in the areas of case operations, PV quality and compliance and planning. Deliver business excellence to improve efficiencies, optimize resource utilization, and strategic oversight of safety systems. Oversee and manage all aspects of pharmacovigilance activities, including adverse event reporting, signal detection, risk management, and benefit-risk assessments. Ensure timely and accurate submission of safety reports to regulatory authorities and maintain compliance with global pharmacovigilance regulations. Develop forecasting methods and critical methods to optimize vendors and third-party partners to deliver efficiencies. Implement and manage robust pharmacovigilance systems and processes to ensure the highest standards of data integrity and quality. Keep abreast of global regulatory requirements, including providing assessments to the GPS LT and working in partnership with the QPPV Office to ensure compliance with all relevant pharmacovigilance regulations and guidelines. Strengthen all aspects of pharmacovigilance for readiness and inspections and audits. From an operations perspective, meets stakeholder needs including but not limited to Global Development, IOPS (Industrial Operations and Product Supply), Commercial, and Business Development. Collaborate with all areas of GPS: Safety Sciences, Pharmacoepidemiology and Risk Management CoE, QPPV office, etc. along with Regeneron areas including GD quality, vendor management, medical affairs, regulatory affairs, and other relevant departments to ensure seamless integration of pharmacovigilance activities and objectives. Provide PV expertise and mentorship to cross-functional teams to support product development, regulatory submissions, and post-marketing activities. Establish and ensure department Key Performance Indicators (KPIs) and PV vendor metrics.
This Role Might Be For You If
Advanced degree in life sciences, pharmacy, medicine, or a related field (MD, PharmD, PhD preferred). Minimum of 20 years of experience in pharmacovigilance within the biotech or pharmaceutical industry. Extensive knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH). Proven track record of leadership and strategic management, team development in pharmacovigilance. Strong understanding of drug development processes and post-marketing surveillance. Excellent communication, interpersonal, and organizational skills. Ability to work collaboratively in a fast-paced, dynamic environment.Strong business acumen and proven ability to collaborate across all organizational levels.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$300,000.00 - $500,000.00Seniority level
Seniority levelExecutive Employment type
Employment typeFull-time Job function
Job functionBusiness Development and Sales IndustriesInternet News Referrals increase your chances of interviewing at BioSpace by 2x Get notified about new Vice President of Global Operations jobs in
Tarrytown, NY . New York City Metropolitan Area $125,000.00-$150,000.00 1 week ago Rockleigh, NJ $200,000.00-$260,000.00 1 week ago Fort Lee, NJ $150,000.00-$200,000.00 2 weeks ago Director, Global Strategy & Creative OperationsVice President, Laboratory Operations - East Region Clifton, NJ $300,000.00-$350,000.00 1 day ago Valhalla, NY $216,000.00-$304,000.00 1 day ago Vice President, Global Clinical Operations New York City Metropolitan Area 1 week ago Vice President, Global Patient Safety OperationsPrivate Equity Portfolio Operations - VP/ Director New York City Metropolitan Area $200,000.00-$250,000.00 13 hours ago AVP Board Relations & Executive Operations Queens, NY $165,000.00-$200,000.00 6 days ago Vice President, Global Environmental, Health and Safety White Plains, NY $175,000.00-$225,000.00 1 week ago Englewood Cliffs, NJ $225,000.00-$275,000.00 2 weeks ago New York City Metropolitan Area 1 day ago Greenwich, CT $155,000.00-$180,000.00 2 weeks ago New York, NY $170,000.00-$180,000.00 4 days ago Senior Director, Global Infrastructure Operations New York, NY $165,000.00-$205,000.00 5 days ago Vice President of Information Security - Governance/Risk/Compliance (Remote) Mahwah, NJ $167,940.00-$272,990.00 1 day ago New York City Metropolitan Area $120,000.00-$150,000.00 1 week ago Platform and Client Operations - Assistant Vice PresidentAlternative Investment Loan Operations, Assistant Vice President Clifton, NJ $85,000.00-$152,500.00 6 days ago Cryptographic Key Management Operations Lead, Vice President, Hybrid Clifton, NJ $130,000.00-$205,000.00 2 weeks ago Manhattan, NY $160,000.00-$180,000.00 2 weeks ago 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