Vice President Global Patient Safety Operations
Vice President Global Patient Safety Operations
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$ 300000 - 500000
1 Vacancy
Job Description
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.
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 crossfunctional 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 crossfunctional teams to support product development regulatory submissions and postmarketing 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 benefitrisk 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 thirdparty 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 crossfunctional teams to support product development regulatory submissions and postmarketing 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 postmarketing surveillance.
- Excellent communication interpersonal and organizational skills.
- Ability to work collaboratively in a fastpaced 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 Companys 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)
Required Experience:
Chief
Employment Type
Full-Time
