Executive / Senior Director, PV & Drug Safety Operations & Compliance

Boston, MA

Executive / Senior Director, PV & Drug Safety Operations & Compliance 2007962
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

 

 

 

 

 

 

 

 

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex 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 our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.

Employee Type:
FullTime

Location:
Boston, MA

Job Type:
Strata: Clin/Reg

Date Posted:
December 22, 2023

Salary:
$280000 - $350000

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