Benefit/Risk Scientist

  • Company: Confidential - 212149629
  • Job Location: Dublin - Ireland
  • Date: June 30, 2020 13:42
  • Employment Type: permanent
  • Experience: Any
  • Job Functions:

Job summary

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...

Job description

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’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’ experience across various aspects of Pharmacovigilance.
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

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