Job Description
The Sr Associate II, Drug Safety is accountable for the end-to-end operational management of Adverse Events of Special Interest (AESIs) across the product lifecycle, including both Clinical Trial and Post-Marketing settings. This role serves as a central coordination hub for internal stakeholders, ensuring timely identification, escalation, and communication of AESIs across the Safety Organization. The Sr Associate II, Drug Safety is accountable for overseeing day-to-day AESI case handling activities outsourced to a vendor, ensuring that case identification, processing, and follow-up are conducted in accordance with Biogen procedures. This includes ongoing vendor oversight, issue resolution, and performance monitoring.
Principle responsibilities
Ensures all AE case processing, in both the Post-Marketing and Clinical Trial settings, is conducted in compliance with regulatory requirements, corporate and departmental procedure and data handling conventions by maintaining and executing oversight plans for vendors (CROs) with case processing responsibilities.
Monitors Biogen Global Safety Database (GSD) and identifies and communicates to appropriate internal stakeholders on events of interest in both Post-Marketing and Clinical Trial settings
Monitors the compliance and health of the case processing workflow continuously through the use of various monitoring reports
Monitors the quality of outsourced AESI case processing activities, ensuring high-quality, clinically appropriate queries are developed and issued for AESIs.
Supports PML adjudication meetings and is accountable for the presentation of the AESI clinical data to the adjudication committee and documentation and dissemination of key decisions to stakeholders
Supports team leadership in execution of AESI -related activities, including contribution to regulatory deliverables for PML, and internal analyses (e.g. FDA AEMS).
Qualifications
Bachelor’s degree in nursing, pharmacy, or other health related profession
2+ years experience in a Drug Safety environment
Solid understanding of worldwide Post-Marketing and Clinical Trial Adverse Event Regulations including GCP, CIOMS, EMA GVP
Strong ability to understand, evaluate, and succinctly summarize technical, scientific and medical information
Ability to interpret regulations and apply the interpretation to departmental SOPs and guidelines
Strong collaborator with effective communication skills in team and matrix environments
Highly organized, adaptable, and able to manage multiple priorities in a fast-paced setting
Critical thinker with strong problem-solving abilities
Exercises sound judgment in workflow assessment and decision-making
Proficient in computer systems and quick to learn new tools and technologies
Preferences
3+ years experience in a clinical setting
Additional Information
Base salary offered is determined through 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 paid 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.