PV Officer/ Senior PV Associate

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 Malaysia and Croatia. Applicants based in the EU and South Africa are also welcome.

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 organization.
• Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits as required.
• Contributes to improvement 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.
• Distribution of SUSARs to enrolled physicians within MAP as per agreement with client.
• 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 Bachelor of Science (BSc) degree.
• Previous experience in Clinical Safety Case Processing.
• 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 characterized 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.
• Excellent attention to detail and ability to work under pressure.
• Extensive knowledge of MS Office applications and systems.
• Outstanding written, verbal, and interpersonal communication skills.
• 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 organized, with the ability to work unsupervised for periods of time.
• Excellent analytical thinking, with the ability to evaluate and present complex safety data.

Benefits

TBC depending on location.