Aggregate Safety Assessment Manager

Aggregate Safety Assessment Manager - 1 yr contract - Leiden

Type: Contract - 12 months

Location: Leiden

Start Date: 1st June

FTE: 40hrs, full-time

Interviews: Next week

Do you have experience in Aggregate Safety Assessment (ASA)? Are you looking for an interim opportunity to work within a global Pharmacovigilance department?

For an international pharmaceutical client based in Leiden, we are looking for an Aggregate Safety Assessment Manager. You will be part of an innovative team that will be responsible for managing writing, and authoring periodic reports , as well as risk assessments and clinical overviews. You will also be responsible for overseeing external vendors and ensuring outsourced work is detailed and accurate

Other day to day responsibilities include

* Compliance with regulatory standards and timely delivery of global and regional periodic documents
* Contribute to quality, accuracy, timeliness and efficiency of ASA activities
* Act as subject matter experience on aggregate safety reports
* Support PV inspection/audit issues contributing to non-PV inspections (e.g. GCP)
* Manages oversight of 10-15 PSURs on a yearly basis

Requirements

* BSc, MSc or PhD in life sciences
* Minimum 5yrs within pharma/biotech/medical device industry in either clinical, regulatory or PV, with direct PV experience
* 2 years aggregate report experience
* Business level fluency in English
* Must have experience in the following: medical writing, vendor management, writing of periodic (PSUR, DSUR), risk assessment and signal evaluation reports
* Knowledge of global pharmacovigilance regulations - US, EU and ICH
* Experience working in a cross-departmental environment - RA and PV
* Excellent interpersonal skills, able to lead teams as well as work autonomously
* Accurate eye for detail when delivering quality documents

Interested? Send your CV to Natasha Bargota before 13th May 2020.

Pharmacovigilance, PV, Aggregate Safety, Safety Reports, Case Processing, Masters, Doctorate, PhD, Pharmaceuticals, Netherlands, Leiden, Randstad, Medical Writing, Periodic Reports, Regulatory, Safety Assessment, Vendor Management, Project Management, PSUR, DSUR, English

Disclaimer: Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age and experience, and we confirm that we are happy to accept applications from persons of any age and experience for this role.