Job Details: Risk Scientist

Jervis Street
Dublin 1
Risk Scientist
Benefit/Risk Scientist - Competitive Salary - TBC

The Role

A great opportunity is being presented for an ambitious scientist
specialising in Pharmacovigilance. A company recognised for its
commitment to providing high quality strategic and operational
services to the pharmaceutical and biotechnology industry is seeking a
Benefit/Risk Scientist to lead by example and ensure that the
company&#**Apply on the website**;s pre-existing quality standards are
continually upheld.

The role would suit an ambitious candidate, as the successful
applicant may act as a PV Group Lead.

The key responsibilities of a Benefit/Risk Scientist include, but are
not limited to:

Preparation, review and submission of Aggregate Reports (PSUR/ DSUR/
PADER/ ACO); Authoring/updating of RMPs; Creation/ maintenance of
CCDSs and creation of supporting documentation (CO, CES, etc.)

Assisting senior team members and management in implementing and
improving processes.

Training/mentoring new team members as necessary.

The Company

Possessing an expert team with broad industry experience in the field
of pharmacovigilance, the company is committed to providing high
quality strategic and operational services to the pharmaceutical and
biotechnology industry.

The company takes pride in its pharmacovigilance department, which is
highly regarded for its consistent provision of comprehensive
outsourced services that ensure compliance across the full lifecycle
for a broad range of product types - covering all bases from
post-market PV to PV auditing and training.

The Person

The key skills and qualities of a Benefit/Risk Scientist:

The successful applicant requires a science degree and 3+
years&#**Apply on the website**; experience across various aspects of

Significant experience in: authoring and reviewing aggregate reports
including PSURs, PADERs, DSURs, ACOs in line with applicable templates
and guidance, authoring and updating RMPs in line with applicable
template and guidelines, managing Company Core Data Sheets (CCDSs),
creating supporting documentation (e.g. Clinical Overview and Clinical
Expert Statement).

Broad knowledge of signal detection methodologies and modalities, and
experience in authoring signal assessment reports

Demonstrable ability to analyse and quantify large volumes of data in
a concise and scientific manner, in keeping with regulatory deadlines.

Strong organisation skills to manage a dynamic workload effectively
and sound communication skills are also required.

If you are keen on joining this exciting, forward thinking company and
taking the next step in your career, then please click the apply now
button to find out more

We need : English (Good)

Type: Permanent
Category: Others

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