Pharmaceutical - Pharmacovigilance Officer Job in Mauritius
Flame Pharma is working on a unique Pharmacovigilance Officer opportunity for a global Pharmaceutical company. This new opportunity will be based in Mauritius. This is a fantastic opportunity to live and work on the tropical island in the South West of the Indian Ocean.
The Pharmacovigilance Officer will oversee all Pharmacovigilance of a global portfolio.
Interface with the PV Team.
Negotiate and finalise safety data exchange agreements with affiliates, distributors and agents and any other institution where such an agreement is required.
Ensure compliance of the various parties to the SDEA through desk audits and on site audits where required.
Evaluate safety information and ensure that these are consistent with approved labeling.
Input into Dear Doctor Letters.
Interaction with Medical Information, Quality and Regulatory Departments.
Oversee any clinical or post-marketing surveillance trials.
Review representative training material from a clinical perspective and ensure compliance with the labeling.
Ensure compliance with operation of ArisG database.
Elevate any significant safety risks put forward a risk mitigation strategy.
Drive Product Safety Review Committee.
Support with PV training for distributors.
Support with responding to Medical Information Enquiries.
Qualifications & Experience:
Knowledge of Pharmacovigilance regulations worldwide (including EU, FDA)
Proven experience in the pharmacovigilance field preferably in the EU
Science / Medical degree
Experience with safety databases including simple searches & coding dictionaries, MedRA (ArisG is preferred)
Experience with conducting PV audits
Knowledge of clinical trial methodology
Experience with Oncology product is an advantage
Ability to review, analyze, interpret and present clinical data.
Good level of computer literacy with Microsoft applications.
Ability to adapt to a new country/environment (if applicable).
Ability to work in a newly established company.
Problem solving skills.
Accuracy and attention to detail.
Ability to work under pressure and to tight deadlines.
Willing to travel.
To apply for this Job or enquire about additional Pharmacovigilance Officer Opportunities across Europe - Contact Flame Pharma free phone on 0800 085 0858 or calling from a mobile on 0115 811 4488 or email firstname.lastname@example.org
Flame Health Associates LLP incorporating Flame Pharma operates as an Employment Agency & Employment Business
Job Code :
Pharmaceutical - Pharmacovigilance Officer Jobs in
Scientific and Technical
Annual salary: £123 - £1234. Frequency: Annually
UK Residency Required?
Registration with a professional organisation such as GMC/NMC/GDC/PIN/ABA