PV Aggregate Report Scientist

Biogen

PV Aggregate Report Scientist

1 year contract

Onsite in Cambridge or remote EST hours

Start date 11/2/2026

79/hour

The PV Aggregate Report Scientist plays a key role within the Safety Surveillance and Aggregate Reports team, overseeing the management and authoring of global pharmacovigilance (PV) aggregate reports, including PSURs, DSURs, PADERs, and local submissions. This position offers a hybrid work arrangement in Cambridge, MA (2-3 days onsite) or fully remote for candidates based in the Eastern Time Zone.

The successful candidate will act as a subject matter expert on worldwide aggregate reporting safety requirements, supporting both internal teams and external stakeholders. Responsibilities include responding to safety-related inquiries, reviewing and authoring medical and scientific safety information, and ensuring high-quality standards across PV documentation through collaboration with vendors and Quality Management teams.

The role involves leading and managing aggregate report projects, maintaining the Aggregate Reports Master Schedule, conducting regulatory reviews, and assessing the impact of global legislation changes. The PV Aggregate Report Scientist will also support the development and implementation of process improvements to enhance consistency in aggregate reporting, signal management, and clinical trial safety oversight.

Candidates must demonstrate strong skills in data interpretation and communication, with the ability to clearly present scientific and medical information. Proven experience in cross-functional collaboration, clinical judgment, and familiarity with pharmacovigilance, drug development, and safety regulations is essential. Strong organizational abilities and independence in task prioritization are required, along with proficiency in standard software and safety database systems.

A bachelor's degree in biological or natural sciences is required; an advanced degree (MSc, PhD, MPH, PharmD, etc.) is preferred. A minimum of five years' experience in pharmacovigilance, including direct involvement in aggregate safety report writing and safety signal management, is necessary for this role.

Must-Have

Skills:

PSUR, DSUR, Aggregate Reporting, Signal Detection, Pharmacovigilance, Safety report writing

Nice-to-Have

Skills:

Data interpretation, Cross-functional collaboration, Clinical judgment, Regulatory, Drug development, Clinical trial safety regulations, Post-marketing safety regulations, Case processing, Expedited reporting, Safety databases, Excel, PowerPoint, Word, Business Objects, Organization, Independence

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.