Loading

366 Biotechnologist jobs found

Subscribe to this job search
Please fill in
Loading
By submitting the form, you agree to our Terms and Conditions and the Privacy Policy.
Please check your email account to complete the subscription.
Job notification
Loading
Job notification
Loading
Loading

Senior Drug Safety and Pharmacovigilance Professional

CTC Resourcing Solution

 
Basel area
add review
Rating submitted

Founded in 1997 and headquartered in Basel, Switzerland, CTC is a specialist life-sciences recruitment organisation. We place specialist talent into contract and permanent positions in the pharmaceutical, biotech, medical devices and CRO industries.

An in-depth experience in life-sciences recruitment combined with an established and extensive local network means that CTC offers clients and candidates the “Gold standard” in recruitment services. With an expertise honed over many years at the cutting-edge of the life-sciences industry, we help companies find people and we help people find companies.

Senior Drug Safety and Pharmacovigilance Professional

Main Responsibilities:

  • Act as EU QPPV, for the assigned PV projects;
  • Expand the current clients‘ PV portfolio;
  • Support the team of PV experts and consultants;
  • Timely conduct of periodic activities and preparation of periodic reports;
  • Provide full pharmacovigilance support including PV system implementation;
  • Supporting the team with activities such as preparation of PV regulatory documentation, safety section of relevant documents and periodic safety reports;
  • Remediate any pharmacovigilance deficiencies found during regulatory or internal audits;
  • Manage pharmacovigilance processes, preparation of SOPs, product safety reviews and literature reviews as required;
  • Work closely with internal and external partners to ensure proper collection and follow up of AE case reports and reconciliation of collected data as required;
  • Ensure timely case processing: triaging, data entry, coding of AE information, quality control and submission of expedited ICSRs to Health Authorities;
  • Safety communication and management of safety issues with Health Authorities, ECs and investigators;
  • Review of individual case safety reports according to SOPs and guidelines;
  • Electronic reporting to Health Authorities;

Qualifications and Experience:

  • MD, PhD or equivalent education;
  • At least 7 years of experience in European/Global Pharmacovigilance;
  • Experience in the pharmaceutical or biotechnical industry, training in a health related field, and knowledge of ICH guidelines, European and Swiss Pharmacovigilance regulations;
  • Vision, experience and drive to further develop a PV department, with an entrepreneurial mindset;
  • Strong network in Drug Safety and PV;
  • Computer proficiency (Word, Excel and PowerPoint) and knowledge of safety databases;
  • Ability to work under pressure and to meet tight timelines;
  • Ability to communicate effectively in English (spoken and in writing), additional language(s), especially German, is desired;
  • Relevant working/residency permit for Switzerland/EU or Swiss/EU-Citizenship required.

Address

CTC Clinical Trial Consulting AG
Mr CTC Resourcing Solutions
Münchensteinerstrasse 41
4052 Basel
+41 61 695 88 66

Website http://www.ctcresourcing.com

Add review

Enter your rating for the company CTC Resourcing Solution here!

Rating submitted