• 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.

The role

• 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.
• Review PSUR.
• 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.

Key Attributes:

• 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 careers@flamepharma.com

Flame Health Associates LLP incorporating Flame Pharma operates as an Employment Agency & Employment Business

Vacancy details

Job Code :
Pharmaceutical - Pharmacovigilance Officer Jobs in

Job Field:
Scientific and Technical

Contract:
Grade:
Any Grade

Speciality:
Clinical Research

Country:
England, Scotland

Location

Aberdeenshire

Min experience:
Any

Annual salary:
£123 - £1234. Frequency: Annually

UK Residency Required?
No

Registration with a professional organisation such as GMC/NMC/GDC/PIN/ABA
GSCC/HPC/BPS/RCP
ASSOC/GOC/BSHAA
APTUK/RCPSYCH/BSDHT
RPS/HPCSA/BACP required?
No

Type of registration?
N/A

Shift work?
No
Jobs4Medical - 11 months ago