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stratacuity
Boston, Massachusetts, United States
(remote)
10 hours ago
Job Type
Full-Time
Min Education
BA/BS/Undergraduate
Job Function
Drug Safety

Description

Location:  Boston, MA (Remote)
Therapeutic Areas: Undisclosed

Job Overview:  This job involves leadership in Drug Safety and Pharmacovigilance, building a team, providing strategic leadership in safety surveillance, and overseeing various aspects of pharmacovigilance operations.
Responsibilities:

  • Build, manage and mentor PV Operations and Compliance team.

  • Responsible for all PV operation and compliance aspects of all products throughout the product lifecycle from First-In-Human to post-marketing.

  • Maintain Global Safety Database (GSBD) and generate reports/LLs from GSBD for Safety Signal Assessment Reports and Aggregate Safety Reports (ASR) such as Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Reports (PADER), IND Annual Safety Reports, and responses to health authorities’ requests for safety information.

  • Build and implement pharmacovigilance systems compliant with global PV regulations.

Requirements:

  • Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D).
  • 15+ years’ experience in PV Operations at global pharmaceutical or biotechnology companies, including 8+ years’ experience as a people manager in PV operations in the clinical trial and post-marketing environments
  • 5+ years’ experience as a Department Head of PVO
  • Extensive experience in ICSR management/processing, aggregate safety reports, Argus Safety Database and MedDRA coding. 

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.



Job ID: 72565649

Please refer to the company's website or job descriptions to learn more about them.

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