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
Originally posted on