Clincial Safety Specialist

The Safety Specialist, N.A. Drug Safety, will be responsible for
coordinating the timely processing, review, and reporting of adverse events
from spontaneous/literature sources and for marketed products from clinical
trials for drugs in development. This individual will also provide support
to Medical Information on queries pertaining to safety of Pharmion products.

Roles & Responsibilities:
Coordinates adverse event collection, medical review, and reporting of
adverse events according to U.S. and international regulations and/or
guidelines, in adherence to standard operating procedures (SOPs) and
regulatory reporting timelines.
Triages and reviews adverse event reports received from spontaneous sources
on marketed products and performs follow-up on such reports as required.
Reviews literature to identify adverse event cases to document on Pharmion
products.
Serves as primary contact for receipt of serious adverse events from N.A.
clinical study sites; interacts directly with study sites to obtain
follow-up information as necessary.
Assists in the preparation of periodic safety update reports.
Serves as initial contact for Medical Information to assist in preparation
of responses to safety questions including ARISg database searches or review
of applicable clinical trial data.
Participates in other clinical development activities as required (e.g.,
safety reporting sections of study protocols under development, clinical
study reports, or investigational drug brochure development/update).
Assists in the development, implementation, and update of N.A. Drug Safety
SOPs.
Provides training on drug safety procedures to Pharmion personnel as
required, to third parties contracted by Pharmion, and to investigators in
studies performed with Pharmion products.
Ensures that all drug safety reporting requirements are met.
Ensures overall high quality of adverse event reports, including their
follow-up.
As a member of Pharmion Global Drug Safety, contributes to worldwide high
standards of drug safety reporting within Pharmion according to N.A. and
global SOPs.
Qualifications:


Energetic, enthusiastic, organized, and sufficiently resilient to
efficiently deal with conflicting demands, with minimal supervision. Ability
to interact cross-functionally within the organization
Proven ability to coordinate process and successfully meet timelines
Detail-oriented individual who constantly seeks ways to improve processes
and practice

Requirements & Education:
Healthcare professional (e.g., BS, Pharmacy; PharmD; BS or Masters Degree in
Nursing)
Good knowledge of adverse event reporting procedures/requirements within the
pharmaceutical industry, with a minimum of 3 years experience.
Experience in clinical trial adverse event reporting.
Good computer/database skills (e.g., MS Word and Excel, safety database
familiarity, MedDRA, WHO-DRL).
Excellent verbal and written communication skills.
Travel may be required ~10%

See www.cyberdivan.com/html/safetylist.htm