Pharmacovigilance Manager
Pharmaceutical company based in Surrey,
Permanent or 12 Month contract
Introduction
Our client is a leading manufacturer of medicines in gastroenterology, women's health and dermatology. Selling internationally, their drug safety team is responsible for ensuring accurate information about the safety of their products across many territories outside the US.
Job Summary
This role is focused on safety reporting for marketed products, and requires previous^experience in pharmacovigilance as this is a small team, managed from Germany. It is essential that all applicants have some knowledge of risk management and signal detection for products across a range of therapy areas. Key tasks are listed below:
Developing and managing systems for adverse event reporting on products
Providing ongoing review of risk-benefit profiles
Technical mastery of the safety database
Integrate and analyse complex data to identify safety signals and trends through:
PSUR and RMP development
Core and local label development
Analysis of safety data
Integrate and analyse data to answer specific safety questions, e.g. from regulatory authorities
Essential Skills & Qualification
Educational background: applied health sciences and or health care professional or related experience
Degree level qualification
Previous demonstrated experience in a PVG role in a pharmaceutical company or CRO
Excellent interpersonal skills when dealing with a wide range^of customers and consumers
Ability to work well within a team, alone and across functions
Written, oral and presentation skills must be of a high standard
Ability to work with databases
Ability to sort through and to interpret complex data and^to develop detailed product knowledge
Supplementary Requirements:
Software Competence: MS Office, ArisG, Argus, Oracle AERS
Valid Driving License: Not required
Working Language(s): English
Requirement for Business Travel: No
Flexible Working Hours: No
Employment Information:
Employer: Pharmaceutical Company
Employment Type: Permanent or agency contract
Hours: Full time
Contract Term: 12 Months
Location: UK Office Based access near M3/ M25 junction
Plan Start Date: by end of August at latest
Employer Benefits:
Company Pension, Life Insurance, Private Healthcare,
Keywords:
PVG, Pharmacovigilance, Safety, Drug Safety, Triage, Case, Narratives, PSUR, ASR, SAEs, ADRs, Argus, Trackwise, MedDRA
Assigned Consultant:^Avril Horn at CSL Recruitment on 01932 234681
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs; applicants will only receive feedback if they demonstrate the skills the role^requires in their application. The role may be remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with^their application to be considered. Do supply supplementary information on required location, notice period and expected salary/day rate if you are a new candidate.