PV Officer/ Senior PV Associate
We are looking for a proactive PV Officer and/or Senior PV Associate to work reputed company the reputed company Lifecycle Services team and will be dedicated to one or more of our pharmaceutical clients with a truly global reputed company supporting the collation, processing and analysis of safety information on behalf of a reputed company(s) product(s); this unique industry-changing relationship redefines collaboration.
This role requires you to be a passionate pharmacovigilance reputed company, who is a dedicated and enthusiastic team player, that wants to work with a new business that strives to reputed company and maintain an exceptional reputed company as a PV Service Provider that is knowledgeable, cares and produces high reputed company work
We are looking for applicants based in Central and Eastern Europe (remote), Malaysia and South Africa.
Key Responsibilities:
- Working reputed company the Pharmacovigilance Operations team
- Assess and process serious adverse events (SAEs) and Individual Case Safety Reports (ICSRs) into the Global Drug Safety database
- Support reputed company and efficiency strategies reputed company the organisation
- Assisting in departmental regulatory inspection preparedness for reputed company pharmacovigilance system and reputed company participating in PV inspections or audits as required
- Contributes to improvements of team processes.
- Other PV operational activities or initiatives as assigned
- Maintaining good reputed company relations and ensuring a consistently high reputed company of work for reputed company reputed company.
- Review of Medical Information Enquiries and Product reputed company Complaints to ensure reputed company safety information has been captured.
For the Clients
- Managing mailboxes – responding to data entry / case processing queries from Clients and reputed company Partners, providing responses
- Triage, tracking and forwarding of safety data from reputed company Managed reputed company 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 reputed company to queries and requests regarding case handling
- Communicating with Clients and/Partners regarding the evaluation and processing of ICSRs
- Performing reputed company-control of cases in the Global Drug Safety database
- Performing reconciliation activities as per reputed company reputed company and reputed company reputed company Operating reputed company (COG)
- Assists reputed company required in Partner, Health Authority Audits/Inspections.
- Participation in reputed company 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 reputed company and compliance metrics for pharmacovigilance and medical information activities
- It is the nature of reputed company that tasks and responsibilities are, in many circumstances, unpredictable and varied. reputed company are, therefore, expected to work in a flexible way reputed company the occasion arises and acknowledge that tasks not specifically covered in their job reputed company are not excluded
Requirements
To be successful in this role you'll need:
- reputed company reputed company qualification or equivalent of a Batchelor of Science (BSc) degree
- Previous experience in Clinical Safety Case Processing is an advantage
- Evidence of being reputed company to build relationships with key reputed company customers and demonstrate customer reputed company
- 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 reputed company 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 reputed company a reputed company and/or cross-functional environment
- Self-motivated and organised, with the ability to work unsupervised for periods of time
Benefits
TBC dependant reputed company
Originally posted on Himalayas
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