Senior Manager, Global Patient Safety - General Medicine

BioSpace; Dublin (OH); Hybride; USD 98 000 - 159 000; Plein temps

Avantages offerts par ce poste

Annual bonuses

Equity awards

Pension/retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance (medical, dental, vision, +1

Paid time off

Family support benefits

Résumé du poste

Regeneron is seeking a Senior Manager in Global Patient Safety (GPS) to lead safety strategies for molecules in clinical development and post-marketing phases. The role focuses on safety data aggregation, review and analysis to support safety interpretation and benefit-risk assessment.

The position involves on-site work in Dublin with cross-functional collaboration on SMT and RSOC/IDMC, plus development of SOPs and process improvements in pharmacovigilance.

Qualifications

• Master's, PhD, or PharmD required.
• 7+ years of risk management experience in pharma/biotech or health authority.
• Ability to apply FDA, EU and ICH pharmacovigilance guidelines.
• Experience with safety system databases and medical case review.
• Strong communication of safety findings (verbal and written).

Responsabilités

• Complete signal detection activities per safety surveillance plan.
• Perform signal evaluation and author the safety evaluation reports.
• Prepare/review DSUR, PSUR, and RMP, and responses to health authority queries.
• Prepare and deliver presentations at SMT meetings; participate in clinical study team meetings for assigned compounds.
• Participate in risk management activities for assigned compounds.
• Represent GPS on cross-functional teams (RSOC, IDMC) and external groups.
• Contribute to process improvements and SOP/WI documentation.

Connaissances

Signal detection

Signal evaluation

Pharmacovigilance

Medical writing

Formation

Master's/PhD/PharmD

Outils

Safety database

Description du poste

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.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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

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.

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.

• 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
• family support benefits

Salary Range (annually)

86,800.00 - 141,200.00