Senior Manager, Drug Safety and Pharmacovigilance - Remote Position

Location
South San Francisco, CA
Posted
Sep 18, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

SENIOR MANAGER, DRUG SAFETY AND PHARMACOVIGILANCE – (Remote Position)

Job Summary:

The Senior Manager will be integral in the day-to-day functioning and overall development of the Pharmacovigilance team. The incumbent will contribute to a full range of drug safety and Pharmacovigilance activities including vendor management, operations, and compliance. In addition, he/she will also function in a company matrix environment with several key groups including Biometrics, Clinical Operations, Clinical Science, Quality Assurance, and Regulatory Affairs.

Essential Duties and Responsibilities:

  • Ensure all safety reports are triaged, processed, reviewed and submitted accordingly per global regulatory requirements and Global Blood Therapeutics (GBT) standard operating procedures
  • Manage and provide oversight for day-to-day interaction with Pharmacovigilance vendor(s)
  • Track cases to completion and adherence to processing timelines
  • Represent Pharmacovigilance in study execution teams for assigned studies
  • Development and implementation of Safety Management Plans between GBT and Pharmacovigilance vendor(s)
  • Assist in signal detection activities
  • Review Analysis of Similar Events for expedited reports
  • Oversee reconciliation of safety data with external teams (safety vendor, Biometrics)
  • Participate in the development and maintenance of Pharmacovigilance standard operating procedures and work guidance
  • Participate in the development of Pharmacovigilance quality management and compliance plans
  • Track compliance metrics
  • Assist in identifying and following-up with corrective action plans from audits and inspections
  • Present or provide internal and external Pharmacovigilance training (e.g. Investigator Meetings, Lunch and Learn)
  • May provide and prepare sections of relevant annual and/or periodic reports

Qualifications:

  • Health care professional (RN, Pharm.D., MD, or equivalent) with, at minimum, 3 years clinical experience
  • 6+ years of global Drug Safety / Pharmacovigilance experience in pharmaceutical industry
  • Excellent knowledge of FDA, EU and ICH guidelines and regulations governing clinical trials and post marketing safety
  • Proven ability to manage Pharmacovigilance vendor(s)
  • Knowledge of medical terminology and general principles of adverse event clinical assessment
  • Knowledge of MedDRA dictionary relevant to adverse event and serious adverse event coding
  • Experience with software based drug safety systems (ARISg a plus, ARGUS, or equivalent)
  • Excellent communication and interpersonal skills, including ability to work cross-functionally and cross-culturally
  • Excellent written and spoken English
  • Ability to listen and think critically (sometime creatively)
  • Experience in public speaking, a plus
  • EudraVigilance certified, a plus

Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.