Job Description

About This Role

The Manager, ICSR Processes and Systems is accountable for providing ICSR processing subject matter expertise and ensure compliance of global PV regulations and ICH standards of ICSR handling within our technology systems, (e.g., safety database) used by Global Case Management.

What You’ll Do

• Review and assess regulatory requirements pertaining to ICSRs and ensure Biogen ICSR procedures efficiently meet regulatory compliance and also in alignment with industry standard practices.
• Review contents of GSD releases and perform impact assessment to Biogen ICSR procedures and execute on identified impacts (e.g. procedural document updates, training material updates, etc.)
• Ensure effective change management, knowledge transfer, and training of GSD releases to internal and external users
• Contribute to system testing through UAT review and execution
• Collaborate with other PV functions on developing, using, and maintaining GxP and non-GxP systems used by GCM for ICSR handling and oversight
• Support global regulatory PV inspections and audits

Who You Are

You have a demonstratable knowledge of GVP regulations and ability to implement these requirements in processes, procedures and systems. You are adaptable, accountable, self driven, and able to manage competing priorities, with key strengths in communication, critical thinking, and problem solving.

Qualifications

Required Skills

• Minimum of Bachelor's level degree in nursing, pharmacy, or other health related profession.
• Minimum 5 Years in Drug Safety Department and Drug Safety systems in the pharmaceutical/ biopharmaceutical industry or equivalent.
• Solid understanding of worldwide Post-Marketing and Clinical Trial Adverse Event Regulations including GCP, CIOMS, EMA GVP
• Direct experience with end-to-end Case Processing of both Clinical Trial and Post-marketing ICSRs
• Excellent communication skills (written and verbal) with strong ability to understand, evaluate, and succinctly summarize technical information
• Excellent organizational skills with an ability to embrace change and handle multiple priorities in a fast-paced environment
• Expert-level proficiency in MS Office Suite and ability to edit and format documents, powerpoints, etc.

Preferred Skills

• Master's or Doctorate level degree in health care related profession preferred
• Experience interacting with third parties (e.g. contract service providers) preferred

Additional Information

The base compensation range for this role is $119,000 - $160,000. Base salary offered is determined though an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees and their families' physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances

• Fitness & Wellness programs including a fitness reimbursement

• Short- and Long-Term Disability insurance

• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)

• Up to 12 company paid holidays + 3 days off for Personal Significance

• 80 hours of sick time per calendar year

• Paid Maternity and Parental Leave benefit

• 401(k) program participation with company matched contributions

• Employee stock purchase plan

• Tuition reimbursement of up to $10,000 per calendar year

• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.