# PV Officer/ Senior PV Associate

**Company:** [Clinigen](http://jobs.workable.com/companies/ihhBKvyQq4UP6WQgsWWAEe.md)
**Location:** Remote
**Workplace:** remote
**Employment type:** Full-time
**Department:** Commercial Functions

[Apply for this job](http://jobs.workable.com/view/cdec2fb8-909a-438d-a518-221d0e4022e9)

## 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 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