Key Skills

Job Description

Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward‑thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‑driven work. ‎‎ Job Description ProductLife Group is looking for Case Specialist (Pharmacovigilance) to join and contribute to the activities of the hub. Responsibilities Responsible for the Quality control of vigilance cases Medical evaluation of reports Data entry of vigilance cases in ad hoc databases or in other formats agreed with the client Follow-up request of vigilance cases by phone/mail Pre-analysis of complex cases prior to data entry Medical Evaluation Of Files On Coding (according to applicable dictionary) Causal relationship between the effects and the intake of suspect products (according to applicable method) The expected/listed or unlisted nature of the events/effects/incidents The seriousness of the events/effects/incidents and the case Identification of submission requirements for each case Validation of certain documents produced by the Data Manager/ Vigilance Associate / documentalist (phone call forms, etc) Closing of vigilance files Identification of requirements and applicable changes to set up ICSR/MLM filters Analysis of inclusion / exclusion of EV/MHRA cases To perform QC for clinical/post-marketing cases Key Contact for specific customers (with the support of an Activity Manager or the Line Manager) Education & Experience Doctor in Pharmacy/ Pharmacist by training Minimum 3 years of experience in a similar position Previous experience working to deadlines Database experience Clinical and Post Marketing case processing experience Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety. Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment. Skills Database experience preferred Knowledge of current regulations Process oriented Rigorous and ability to work in a team Use of Microsoft Office tools Ability to multitask Flexibility Excellent communication skills ‎ Ready to take the next step? Apply today and join a global, innovative team that’s shaping the future of life sciences and empowering people to make a real impact in healthcare.

Core Responsibilities

Perform quality control, medical evaluation, coding, and data entry for clinical and post-marketing pharmacovigilance cases. Assess case seriousness, causality, reporting requirements, and regulatory filters; follow up on cases and support specific customers.

Requirements

Requires training as a Doctor of Pharmacy or Pharmacist and at least three years of experience in a similar role. Candidates should have clinical and post-marketing case-processing experience, knowledge of pharmacovigilance principles and applicable regulations, database experience, and strong communication and organizational skills.