Medical Director Pharmacovigilance (3426)
Company: Execu-Search Group
Location: Somerville
Posted on: January 12, 2021
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Job Description:
local preference but can be FULLY remote Experienced Medical
Director or Exceptional PV Scientist to Provide Strategic and Hands
On Development of NDA Submission Activities OBJECTIVES: ---
Oncology experience preferred --- Preferable experience with
strategy for NDA submissions --- Understanding of safety data flow
and data analysis for NDA submission, ability to develop timelines
for documents preparation, provide hands on work in NDA submission
activities, e.g., data analysis and writing of ISS, development of
CCSI/CCDS and subsequent label,, participation in safety data and
content verification for module 2.7.3 Summary of safety as well as
module 2.5 Clinical overview-risk/benefit analysis); module 2.7.3
Summary of efficacy (safety contributes to review module 2.7.4
summary of safety; and responding to an expected barrage of ongoing
queries from Health Authorities. --- Ability to work with large
volume of data and TLFs is an essential skill for this position.
--- Additional activities may include Clinical Study reports
writing, protocol amendments writing, TLFs review and
communications with biostatisticians. --- Experience in Risk
Management Plan (RMP) content writing and inter-functional
coordination is desirable. --- Able to quickly learn safety profile
of an assigned product, perform routine PV activities like daily
SAEs review, monthly signal detection (including running of reports
from a safety database), preparation of quarterly safety data
overview and slides preparation for quarterly safety review
meetings for designated global/regional product(s), in
collaboration with product global safety lead. ACCOUNTABILITIES:
--- Intimate knowledge of safety, including any emerging safety
concerns and development risk/benefit profile --- Responsible for
development of documents and for negotiation with Regulatory
authorities on safety matters involving these compounds. This
includes but is not limited to: authorship of safety summaries to
support development of the PI/SmPC, significant contribution to
NDAs, --- --- This position will perform activities of both Senior
Level PV Scientist responsible for data preparation and analysis
and of Global PV physician: - Review and oversight of safety data,
both non-clinical and clinical in collaboration with an assigned
product Global Safety Lead - Review of protocols, SAPs, clinical
study reports, IBs, and other documents developed for submission to
regulatory authorities in collaboration with an assigned product
Global Safety Lead - Preparation and review of safety data -
Participation in the development of a Risk Management Plan -
Participation in data analysis and writing of regulatory submission
documents- EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: --- Prefer
MD, PhD, or PharmD with minimum of 6 years experience in
Pharmacovigilance, experience with leading NDA submission
activities is highly desirable --- Ability to work with large sets
of data --- Strategical thinking and ability to make high level
decisions --- Excellent oral and written communication skills
including ability to present to large internal/external groups ---
Good level of computer literacy with Microsoft applicationsType:
ContractCategory: LIFE
Keywords: Execu-Search Group, Somerville , Medical Director Pharmacovigilance (3426), Executive , Somerville, Massachusetts
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