PV Aggregate Reports Scientist

Biogen; Cambridge (MA); Presencial; USD 122.000 - 163.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Paid time off

Bonuses and equity opportunities

Descripción de la vacante

Biogen is seeking a PV Aggregate Reports Scientist to lead the authoring and program management of global safety reports such as PSURs, DSURs, and PADERs. The role requires expert pharmacovigilance knowledge and cross-functional collaboration within Safety, Clinical Development, and vendor oversight teams.

You will interpret complex safety data, respond to regulatory inquiries, and help drive process improvements and consistency across product groups.

Formación

• Bachelor's Degree in biologic or natural science.
• Minimum 5 years of pharmacovigilance experience, including aggregate safety reports writing and safety signal management.
• Familiarity with pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations.
• Strong organizational skills and ability to prioritize independently.
• Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
• Knowledge of common safety database systems.

Responsabilidades

• Lead and manage all aspects of aggregate safety report authoring and project management.
• Serve as SME on safety requirements in cross-functional forums.
• Support the Aggregate Reports Master Schedule and stakeholder reviews.
• Review worldwide regulations and provide impact assessments.
• Assist in writing responses to safety questions from regulators.
• Contribute to process improvements and signal management.
• Support implementation of new and existing processes.
• Interpret and present scientific data clearly in writing and speaking.
• Collaborate with Safety, Clinical Development, and other teams.
• Apply clinical judgment to interpret case information for staff guidance.

Conocimientos

Pharmacovigilance

Aggregate safety reports

Project management

Regulatory knowledge

Communication skills

Organizational skills

Data interpretation

Educación

Bachelor's degree in biological or natural science

Advanced degree (MSc/PhD/MPH/PharmD)

Herramientas

Excel

PowerPoint

Microsoft Word

Business Objects

Descripción del empleo

About This Role:

As a PV Aggregate Reports Scientist, you will be an integral part of the Safety Surveillance and Aggregate (SSA) Reports team, responsible for managing the processes for all aggregate reports, including PSURs, DSURs, PADERs, and local reports. Your role involves serving as a subject matter expert on aggregate reporting safety requirements worldwide, providing critical insights to the PV Scientist team and cross-functional partners. You will respond to safety inquiries from both internal and external stakeholders, review and support the authoring of medical and scientific safety information, and work closely with vendors and the vendor oversight team, as well as the Quality Management team, to ensure high-quality standards. Your contributions will also support process improvement initiatives, collaborating with the PV Sciences group and other cross-functional teams to develop and maintain compliant processes that enhance efficiency and lead to consistent work practices across assigned product groups.

What You\'ll Do:

• Lead and conduct, independently and/or collaboratively, all aspects of authoring and project management of aggregate safety reports.


• Serve as a subject matter expert on safety requirements and pharmacovigilance activities, representing processes in cross-functional forums.


• Support the Aggregate Reports Master Schedule, including production, updates, and stakeholder reviews.


• Conduct worldwide legislation reviews related to aggregate reports and provide impact assessments.


• Assist in authoring responses to safety questions from regulatory authorities in collaboration with stakeholders.


• Contribute to process improvement initiatives and consistency regarding aggregate reports and signal management.


• Support the implementation and maintenance of new and existing processes.


• Interpret, analyze, and present scientific and medical data clearly in both verbal and written formats.


• Collaborate effectively within the team and with external colleagues across Safety, Clinical Development, and other functions.


• Apply clinical judgment to interpret case information and guide staff in interpretation.

Who You Are:

You are someone who thrives in a collaborative environment and brings a strong sense of organization and attention to detail to your work. Your background in pharmacovigilance and your experience with aggregate safety reports equip you to manage complex projects with minimal supervision. You communicate scientific and medical data clearly and effectively, and your ability to interpret and present information is matched by your commitment to maintaining high-quality standards. Your proactive approach to process improvement and your ability to work effectively with cross-functional teams make you a valued contributor to the organization.

Required Skills:

• Bachelor\'s Degree in biologic or natural science.


• Minimum 5 years of pharmacovigilance experience, including aggregate safety reports writing and safety signal management.


• Familiarity with pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations.


• Strong organizational skills and ability to prioritize independently.


• Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).


• Knowledge of common safety database systems.

Preferred Skills:

• Advanced degree (MSc, PhD, MPH, PharmD, etc.).


• Advanced understanding of medical concepts and terminology.


• Demonstrated authoring experience within pharmacovigilance.


• Strong collaborative skills within cross-functional teams.

Job Level: Management

Additional Information

The base compensation range for this role is: $122,000.00-$163,250.00

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 participat