PV Officer/ Senior PV Associate

About this role

We are looking for a proactive PV Officer and/or Senior PV Associate to work within the Clinigen Lifecycle Services team and will be dedicated to one or more of our pharmaceutical clients with a truly global presence supporting the collation, processing and analysis of safety information on behalf of a Client(s) product(s); this unique industry-changing relationship redefines collaboration.
This role requires you to be a passionate pharmacovigilance professional, who is a dedicated and enthusiastic team player, that wants to work with a new business that strives to gain and maintain an exceptional reputation as a PV Service Provider that is knowledgeable, cares and produces high quality work
We are looking for applicants based in Central and Eastern Europe (remote), Malaysia and South Africa.

Key Responsibilities:
Working within the Pharmacovigilance Operations team
Assess and process serious adverse events (SAEs) and Individual Case Safety Reports (ICSRs) into the Global Drug Safety database
Support quality and efficiency strategies within the organisation
Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits as required
Contributes to improvements of team processes.
Other PV operational activities or initiatives as assigned
Maintaining good client relations and ensuring a consistently high quality of work for each client.
Review of Medical Information Enquiries and Product Quality Complaints to ensure all safety information has been captured.

For the Clients
Managing mailboxes – responding to data entry / case processing queries from Clients and Client Partners, providing responses
Triage, tracking and forwarding of safety data from client Managed Access Programmes.
Case processing of SAEs and/or ICSRs
Case regulatory reporting; preparing relevant cases for submission and sending to the relevant Regulatory Authorities
Working on E2B/R3 format reporting and Case Finalization; reading error messages and taking steps to correct cases as a result of negative acknowledgments.
Supporting investigation of cases of non-compliance of SAEs/ICSRs
Performing Literature Article reviews
Performing follow-up related to queries and requests regarding case handling
Communicating with Clients and/Partners regarding the evaluation and processing of ICSRs
Performing quality-control of cases in the Global Drug Safety database
Performing reconciliation activities as per Client contracts and each Client Operating Guideline (COG)
Assists when required in Partner, Health Authority Audits/Inspections.
Participation in Client audits and inspections

Additional Duties
The list of duties is not intended to be exhaustive, but gives a general indication of the tasks involved;
Support the collation and dissemination of quality and compliance metrics for pharmacovigilance and medical information activities
It is the nature of the company that tasks and responsibilities are, in many circumstances, unpredictable and varied. All employees are, therefore, expected to work in a flexible way when the occasion arises and acknowledge that tasks not specifically covered in their job description are not excluded

Requirements
To be successful in this role you'll need:
Healthcare Professional qualification or equivalent of a Batchelor of Science (BSc) degree
Previous experience in Clinical Safety Case Processing is an advantage
Evidence of being able to build relationships with key internal and external customers and demonstrate customer focus
Attention to detail and the ability to work effectively in an environment characterised by tight timelines and changing priorities
Excellent organizational and prioritization skills and strong analytical / problem solving skills
Excellent oral and written communication skills
Ability to build relationships with key internal and external customers
Extensive knowledge of MS Office Applications and systems
Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
Proven ability to work collaboratively within a matrix and/or cross-functional environment
Self-motivated and organised, with the ability to work unsupervised for periods of time

Benefits
TBC dependant on location