Associate Medical Director, Global Safety Physician

Biogen; Boston (MA); On-site; USD 184,000 - 253,000; Full time

Benefits offered by this job

Medical/Dental/Vision Insurance

Fitness & Wellness reimbursement

Paid vacation & holidays

401(k) with company match

Stock purchase plan

Tuition reimbursement

Job summary

Biogen is seeking a Global Safety Physician based in Cambridge, MA, to oversee global pharmacovigilance for investigational and marketed products. You will review safety data, design trials, and manage benefit-risk profiles while representing Safety in internal and external meetings.

The role requires MD with 3+ years in pharma or clinical care, plus pharmacovigilance experience. Competitive compensation and a broad benefits package are offered.

Qualifications

• MD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred.
• Minimum 3+ years' experience in the pharmaceutical industry or clinical care setting; ideally 1+ years of overall experience specific to pharmacovigilance.
• Prior experience in clinical trials; academic and/or industry.
• Knowledge of pre- and post- marketing US and EU regulations.

Responsibilities

• Manage safety surveillance for assigned products and collaborate with PV scientists.
• Conduct analyses of safety trial data and adverse events handling.
• Decide on seriousness, expectedness, and causality for safety reports.
• Provide safety leadership for clinical development programs and regulatory interactions.

Skills

Leadership

Global collaboration

Clinical development

Education

MD degree

Neuroscience subspecialty

Psychiatry subspecialty

Rare diseases

Job description

Job Description

The Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. The Global Safety Physician will represent Biogen Safety in internal and external meetings. The Global Safety Physician can be appointed as the Global Safety Officer for a specific product. Responsible for keeping upper management informed of safety issues. The Global Safety Physician will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through their life cycle. This person will also interact with multiple levels of management within Biogen, external stakeholders in the medical community as well with global regulatory authorities.

Principal Accountabilities

• Manage safety surveillance for assigned products; Collaborate with PV scientists and other stakeholders; Conduct analyses of safety trial data; Ensure adequacy of summarizing and handling of adverse events for investigational and/or marketed Biogen products including decisions on seriousness, expectedness, and causality.
• Provide safety strategic leadership for clinical development programs; Integrate the safety scientific component to build a strategic framework for clinical development plans.
• Develop and maintain relationships with counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.
• Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timelines and timelines set by regulatory authorities.

Who You Are

You are a proven leader and strive on developing, executing and advancing successful programs in development. You have experience working / leading high performing teams; providing the necessary guidance and mentoring for all to reach their goals. This position is based in Cambridge, MA (USA).

Qualifications

• MD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred.
• Minimum 3+ years' experience in the pharmaceutical industry or clinical care setting; ideally 1+ years of overall experience specific to pharmacovigilance.
• Prior experience in clinical trials; academic and/or industry.
• Knowledge of pre- and post- marketing US and EU regulations.

Additional Information

The base compensation range for this role is: $184,000.00-$253,000.00. 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 onto learn more about Biogen.

EEO Statement

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.

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