Senior Manager, Global Patient Safety - General Medicine

BioSpace; Dublin (OH); On-site; USD 87,000 - 141,000; Full time

Job summary

Regeneron, a leader in science and medicine, is seeking a Senior Manager in Global Patient Safety in Dublin. You will drive safety strategies for molecules in clinical development and post-marketing, with focus on signal detection, evaluation, and safety reporting.

The role requires advanced degrees and extensive pharmacovigilance experience, with responsibility for DSUR/PSUR/RMP and cross-functional collaboration, onsite three days per week in Dublin.

Qualifications

• Master's, PhD, or PharmD required.
• Experience in pharmacovigilance within pharma/biotech or health authority.
• Ability to apply FDA, EU and ICH safety guidelines.

Responsibilities

• Complete signal detection activities per safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare and review DSUR, PSUR, and RMP documents.
• Deliver presentations at SMT meetings and participate in study teams.
• Engage in risk management activities for assigned compounds.
• Represent GPS on cross-functional/regulatory committees.
• Contribute to SOPs, WIs and related documents.

Skills

Signal detection

Safety evaluation

Pharmacovigilance

Clinical safety data

Education

Master's, PhD or PharmD

Tools

Safety database

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our Patient Safety team. The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.

When & Where

Work Location: Dublin, IRE

3 days per week on site

Discover Your Role

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation for any identified signals and author the safety evaluation reports
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
• Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
• Participate in other risk management activities as appropriate for assigned compounds
• We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

This Role Requires

• Minimum a Master's, PhD, or PharmD
• Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
• Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
• Ability to work with a safety system database for purposes of medical case review and simple queries
• Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize
• Ability to effectively communicate (verbal and written) safety findings

#GDPSJobs

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. For more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

86,800.00 - 141,200.00