Sr Associate II, Drug Safety

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

• Bachelors 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 technicalscientificand 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 $10000 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 onto learn more about Biogen.

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.