myGwork - LGBTQ+ Business Community · 1 day ago

Associate Director, Pharmacovigilance Scientist

United States

Full-time

Remote

Director/Executive

8+ years exp

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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

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

PharmacovigilanceAggregate Safety ReportsRegulatory Agency ResponsesProcess ImprovementSafety Signal ManagementClinical Trial ExperiencePost-Marketing ExperienceBiologic Science DegreeNatural Science DegreeMScPharmDMentoring SkillsCollaboration Skills

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.