Drug Safety Scientist
Company: Axelon Services Corporation
Location: Chicago
Posted on: July 1, 2025
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Job Description:
Drug Safety Scientist Remote, candidates should be in EST only
12 month 8AM-5 PM Pay: $ 48.95 per hour Should have
Bachelors/Masters degree in Science(Pharmacy, Bio Technology or
Chemistry) Experience in pharmacovigilance is a must(5 years).
Candidates should live in EST only! The Drug Safety (DS) Scientist
works within Drug Safety & Risk Management group. S/he performs
pharmacovigilance tasks and prepares submission-ready regulatory
documents within agreed time frames and to a high standard of
accuracy, in compliance with client Healthcare business rules,
standard operating procedures and global and local regulatory
requirements. The Drug Safety (DS) Scientist will provide
scientific support to Drug Safety physicians for safety scientific
activities from clinical trials and post-marketing experience.
Primary responsibilities- Author aggregate safety reports required
by health authorities such as, Development Safety Update Reports
(DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), US
Periodic Adverse Drug Experience Report (PADER). Produce high
quality, accurate and fit-for-purpose evaluation documents with
clear conclusion, in response to internal or regulatory authority
safety-related requests. Run accurate queries and provide standard
outputs of the data from the safety database; create draft
reports/data tables and to perform searches of the safety database
for ad-hoc queries. Support preparation of RMP and post-marketing
safety monitoring activities. Review publications from worldwide
medical/scientific literature to identify signals and applicable
information for inclusion in aggregate safety reports. Conduct
routine and ad-hoc signal detection and evaluate safety data and
signals as part of ongoing pharmacovigilance activities. This
includes the ability to summarize data from multiple sources and
authoring signal evaluation reports. Provide support to the
compilation of information for reference safety information
(including Company Core Safety Information). Participate and
contribute to Safety Management Team meetings. Support Drug safety
physicians in handling issues related to both clinical and
post-marketing safety, as needed. Perform other duties related to
the position as necessary and as defined in SOPs and/or at the
request of supervisor. Minimum of 3 years of
pharmaceutical/biotechnology PV experience, including clinical
trial and post-marketing experience Bachelor or Master of
Science(required) Experience in authoring of aggregate safety
reports. Strong knowledge in FDA, EU, ICH guidelines, initiatives
and regulations governing pharmacovigilance. Experience with coding
according to the Medical Dictionary for Regulatory Activities
(MedDRA). Ability to function in an environment of rapidly changing
priorities and to manage multiple projects simultaneously while
maintaining a high level of quality, accuracy and attention to
detail. Excellent oral and written communication skills. Excellent
computer skills, including Microsoft Word, PowerPoint and
Excel.
Keywords: Axelon Services Corporation, Hammond , Drug Safety Scientist, Science, Research & Development , Chicago, Indiana
