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Clinigen

Accelerating access to medicines, globally.

PV Officer/Senior PV Associate

GeneralGeneralFull TimeRemoteSeniorTeam 1,001-5,000Since 2010H1B No SponsorCompany SiteLinkedIn

Location

Malaysia

Posted

1 day ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglish

Job Description

PV Officer/Senior PV Associate

Clinigen

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

Job 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

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