51 applicants

Company

Biogen · 1 day ago

Associate Director, Aggregate Report Scientist

United States

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

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BiotechnologyHealth Care

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Lead independently and collaboratively all aspects of substantive projects including authoring aggregate safety reports and responses to regulatory agency requests.

Serve as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as in-depth Aggregate Reports knowledge. Serve as example for behaviors that lead to high quality outputs.

Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview.

Identify process non-compliance, gaps or inefficiencies and lead initiatives for process improvement, implements and maintains processes. Manage corrective actions when non-compliances are identified.

Oversee and mentor PV Scientist staff.

Qualification

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PharmacovigilanceAggregate Safety ReportsRegulatory Agency ResponsesProcess ImprovementSafety Signal ManagementBiologic Science DegreeNatural Science DegreeAdvanced DegreeClinical Trial ExperiencePost-Marketing Experience

Required

Bachelor’s Degree in biologic or natural science OR Advanced degree (MSc, PhD, MPH, PharmD, etc.)

Minimum 8-10 years Pharmacovigilance experience, including experience in aggregate safety reports writing, responses to health authorities, and safety signal management in both clinical trial setting and post-marketing.

Company

Biogen

Glassdoor

3.8

Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.

Founded in 1978

Cambridge, Massachusetts, USA

5001-10000 employees

https://www.biogen.com/en_us/home.html

H1B Sponsorship

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