Senior Director, Pharmacovigilance

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Senior Director, Pharmacovigilance

Cambridge, Massachusetts

|

Direct (Permanent) Full Time

|

NA

Cambridge, Massachusetts

Direct (Permanent) Full Time

NA

March 27, 2024

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Job ID: P1371355BOSSCM_1711545432

March 27, 2024

Job ID: P1371355BOSSCM_1711545432

Job Summary

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Position Overview:

This senior PV role will be responsible for oversight and management of activities pertaining to our client's drug safety and pharmacovigilance and have line management responsibilities for PV scientist(s). In addition will be responsible for deliverables associated with assigned product(s).

Responsibilities:

  • Management, mentorship, and development of PV Scientist(s)
  • Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for the assigned product(s)
  • Provide PV subject matter expertise on Clinical Development Teams and other cross-functional platforms throughout the company
  • Facilitate internal cross-functional Safety Management Committee meetings; includes coordinating materials, data presentation and all outputs, and agenda
  • Review and provide PV input for development of protocols, IBs, CSRs and other relevant study documents
  • Project lead for DSURs and subject matter contributor to other aggregate documents such as Investigator Brochure
  • Oversight of vendor specific to PV deliverables
  • Provide strategic direction for the PV department on initiatives such as functional service provider model and global safety database strategy

Qualifications:

  • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
  • Minimum 12 years' pharmaceutical industry experience, including a minimum of 8 years' experience in PV
  • Knowledge of MedDRA terminology and its application
  • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data
  • Experience in the preparation and authoring of pre- and post- aggregate safety reports
  • Experience working on BLA/MAA filings is preferred
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
P1371355BOSSCM_1711545432

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™