Clinigen
pharmaceutical
PVOfficer/SeniorPVAssociate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“PV Officer/ Senior PV Associate at Clinigen. Skills: Pharmacovigilance, Safety information collation, Safety information processing, Safety information analysis, Case processing, Client relations. 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”
What You'll Achieve.
Consistently high quality of work for each client; Support quality and efficiency strategies within the organisation
Industry & Context.
analytical / problem solving skills
Applicants based in Central and Eastern Europe (remote), Malaysia and South Africa
What They're Looking For.
Must Have
Healthcare Professional qualification or equivalent of a Batchelor of Science (BSc) degree, Ability to build relationships with key internal and external customers, 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 analytical / problem solving skills, Excellent oral and written communication skills, 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
Nice to Have
Previous experience in Clinical Safety Case Processing is an advantage
What You'll Do.
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
Managing mailboxes – responding to data entry / case processing queries from Clients and Client Partners
tracking and forwarding of safety data from client Managed Access Programmes
Case processing of SAEs and/or ICSRs
Case regulatory preparing relevant cases for submission and sending to the relevant Regulatory Authorities
Working on E2B/R3 format reporting and Case 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
Support the collation and dissemination of quality and compliance metrics for pharmacovigilance and medical information activities
How You'll Work.
Team & Collaboration
Working within the Pharmacovigilance Operations team; Proven ability to work collaboratively within a matrix and/or cross-functional environment
Communication Scope
Excellent oral and written communication skills
Full Job Description
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
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