Lead Drug Safety Associate - CSI-IS-025 - Stamford, CT We are
looking for Lead Drug Safety Associate for our client in Stamford,
Job Title: Lead Drug Safety Associate
Job Location: Stamford, CT
Job Type: Contract
“W2 candidates are encouraged to apply. We are unable to sponsor
H1b or work with third-party candidates at this time.”
The incumbent must have good knowledge of the PV end-to-end
process and will leverage this knowledge to implement
The incumbent will be responsible for the implementation,
execution, training, continuous improvement, and oversight of
matters pertaining to PV alliances and policies.
The incumbent will liaise with internal and external
stakeholders, subsidiaries, Independent Associated Companies
(IACs), business partners, and vendors as needed to establish and
maintain policies as well as implement any corrective/preventive
actions needed to ensure compliance.
Establishes and maintains departmental procedures; oversees the
training and continuous improvement.
Support DSP in pharmacovigilance activities including signal
detection and tracking activities, literature surveillance,
oversight of medical review performed by an outsourced vendor.
Collaborate with DSP safety physicians with PV activities as
Writing safety analysis reports.
Oversight of medical review and aggregate report activities
performed by outsourced vendors.
Support clinical project teams for investigational products;
provide project teams providing expertise in PV activities.
Collaborate with Clinical Research and Development, Medical
Affairs, Regulatory Affairs.
Provide Leadership in the development, implementation, and
maintenance of robust procedures for PV activities within the DSP
Participate in the Safety Evaluation Group with local and global
drug safety colleagues to monitor and discuss safety signal
Contribute to the writing and compilation of PADERs, Annual
reports, and PSURs/PBRER.
Author and review department SOPs as needed.
Participate in Regulatory Inspections, external audits, and
Drug safety representative on client intradepartmental committee
for review and approval of clinical trial protocol language and
clinical study processes.
Acts as a Subject Matter Expert in PV regulatory inspections and
Collaborates with internal stakeholders and client subsidiaries
to establish and maintain the Corporate AE Policy.
Collaborate with Drug Safety Operations and Drug Safety Systems
as needed, to ensure appropriate metrics per SOP.
Up-to-date knowledge of PV regulations and best practices.
Thinks globally and considers present and future impacts when
Experience with PV vendor and business partner oversight and
Strong negotiation and problem-solving skills.
Analytical skills and attention to detail.
Accountability – takes ownership of deliverables.
Education and Experience:
This job requires a Bachelor’s degree (advanced degree
preferred) in life science or healthcare (e.g. nursing, pharmacy)
with 10 years of experience in a pharmaceutical/biopharmaceutical
company and 7 years of Drug Safety experience.
Published at 08-04-2020
Viewed: 13 times
Today's Date: Thu Aug 06 2020
Cynet Systems is an Equal Opportunity Employer
At Cynet Systems, we are committed to providing an environment
of mutual respect where equal employment opportunities are
available to all applicants and teammates without regard to race,
color, religion, sex, pregnancy (including childbirth, lactation,
and related medical conditions), national origin, age, physical and
mental disability, marital status, sexual orientation, gender
identity, gender expression, genetic information (including
characteristics and testing), military, women, minority and veteran
status, and any other characteristic protected by applicable law.
Cynet Systems believes that diversity and inclusion among our
teammates are critical to our success as a global company, and we
seek to recruit, develop and retain the most talented people from a
diverse candidate pool.