{"id":3421315,"url":"https://alion.io/job/biogen-pv-aggregate-reports-scientist","title":"PV Aggregate Reports Scientist","company":{"id":449685,"name":"Biogen","domain":"biogen.com","url":"https://alion.io/company/biogen-2","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":83,"open_postings":21,"ghost_share":0,"stale_share":0.667,"repost_share":0,"time_to_fill_p50_days":35,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cambridge, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":122000,"max":163250,"currency":"USD","period":"year","gross":null,"usd_annual":163250},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"SAP BusinessObjects","optional":false}],"status":"live","first_seen_at":"2026-10-28T21:01:46Z","employer_posted_date":"2026-10-28","last_verified_at":"2026-10-31T03:10:19Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"About This Role:\nAs 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.\nWhat You’ll Do:\nLead and conduct, independently and/or collaboratively, all aspects of authoring and project management of aggregate safety reports.\nServe as a subject matter expert on safety requirements and pharmacovigilance activities, representing processes in cross-functional forums.\nSupport the Aggregate Reports Master Schedule, including production, updates, and stakeholder reviews.\nConduct worldwide legislation reviews related to aggregate reports and provide impact assessments.\nAssist in authoring responses to safety questions from regulatory authorities in collaboration with stakeholders.\nContribute to process improvement initiatives and consistency regarding aggregate reports and signal management.\nSupport the implementation and maintenance of new and existing processes.\nInterpret, analyze, and present scientific and medical data clearly in both verbal and written formats.\nCollaborate effectively within the team and with external colleagues across Safety, Clinical Development, and other functions.\nApply clinical judgment to interpret case information and guide staff in interpretation.\nWho You Are:\nYou 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.\nRequired Skills:\nBachelor’s Degree in biologic or natural science.\nMinimum 5 years of pharmacovigilance experience, including aggregate safety reports writing and safety signal management.\nFamiliarity with pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations.\nStrong organizational skills and ability to prioritize independently.\nBasic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).\nKnowledge of common safety database systems.\nPreferred Skills:\nAdvanced degree (MSc, PhD, MPH, PharmD, etc.).\nAdvanced understanding of medical concepts and terminology.\nDemonstrated authoring experience within pharmacovigilance.\nStrong collaborative skills within cross-functional teams.\nJob Level: Management Additional Information\nThe base compensation range for this role is: $122,000.00-$163,250.00Base 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.\nRegular 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.\nIn 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:\nMedical, Dental, Vision, & Life insurances\nFitness & Wellness programs including a fitness reimbursement \nShort- and Long-Term Disability insurance\nA minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)\nUp to 12 company paid holidays + 3 paid days off for Personal Significance \n80 hours of sick time per calendar year\nPaid Maternity and Parental Leave benefit \n401(k) program participation with company matched contributions\nEmployee stock purchase plan \nTuition reimbursement of up to $10,000 per calendar year \nEmployee Resource Groups participation\nWhy Biogen?\nWe 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.\nAt 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 Biogen.\nAll 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. 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