PV Officer/Senior PV Associate

This is a fully remote position, open to applicants in Malaysia.

📋 Description

• We are seeking a proactive PV Officer and/or Senior PV Associate to join the Clinigen Lifecycle Services team, dedicated to supporting one or more of our pharmaceutical clients with a truly global footprint. This role involves the collation, processing, and analysis of safety information for Client(s) product(s), fostering a unique, industry-altering collaborative relationship.

• The ideal candidate is a passionate pharmacovigilance professional, dedicated and enthusiastic, eager to contribute to a new business that aims to establish and uphold an outstanding reputation as a knowledgeable and caring PV Service Provider, committed to delivering high-quality work.

• We invite applications from individuals located in Central and Eastern Europe (remote), Malaysia, and South Africa.

• **Key Responsibilities:**

• - Collaborating within the Pharmacovigilance Operations team.

• - Evaluating and processing serious adverse events (SAEs) and Individual Case Safety Reports (ICSRs) into the Global Drug Safety database.

• - Supporting quality and efficiency initiatives within the organization.

• - Assisting in departmental regulatory inspection readiness for the pharmacovigilance system and actively participating in PV inspections or audits as necessary.

• - Contributing to the enhancement of team processes.

• - Undertaking other PV operational activities or initiatives as assigned.

• - Maintaining positive client relations and ensuring consistently high-quality work for each client.

• - Reviewing Medical Information Inquiries and Product Quality Complaints to ensure all safety information is accurately captured.

• **For the Clients**

• - Managing mailboxes by addressing data entry/case processing inquiries from Clients and Client Partners, providing timely responses.

• - Triage, tracking, and forwarding safety data from client Managed Access Programs.

• - Processing cases of SAEs and/or ICSRs.

• - Regulatory reporting of cases; preparing relevant cases for submission and forwarding to appropriate Regulatory Authorities.

• - Handling E2B/R3 format reporting and Case Finalization; interpreting error messages and taking corrective actions based on negative acknowledgments.

• - Assisting in the investigation of cases involving non-compliance of SAEs/ICSRs.

• - Conducting Literature Article reviews.

• - Following up on queries and requests related to case handling.

• - Communicating with Clients and/or Partners regarding the evaluation and processing of ICSRs.

• - Performing quality control of cases in the Global Drug Safety database.

• - Conducting reconciliation activities in accordance with Client contracts and each Client Operating Guideline (COG).

• - Assisting as needed during Partner and Health Authority Audits/Inspections.

• - Participating in Client audits and inspections.

• **Additional Duties**

• - The duties listed are not exhaustive but provide a general overview of involved tasks.

• - Supporting the collection and distribution of quality and compliance metrics for pharmacovigilance and medical information activities.

• - Given the nature of the company, tasks and responsibilities may often be unpredictable and varied. All employees are expected to work flexibly when needed and accept that tasks not explicitly mentioned in their job description are not excluded.

⛳️ Requirements

• **To excel in this role, you will need:**

• - A Healthcare Professional qualification or an equivalent Bachelor of Science (BSc) degree.

• - Previous experience in Clinical Safety Case Processing is advantageous.

• - Evidence of the ability to build relationships with key internal and external customers while demonstrating a customer-focused approach.

• - Strong attention to detail and the capability to thrive in an environment characterized by tight deadlines and shifting priorities.

• - Excellent organizational and prioritization skills, along with strong analytical and problem-solving capabilities.

• - Outstanding oral and written communication skills.

• - Ability to establish relationships with key internal and external customers.

• - Extensive proficiency in MS Office Applications and systems.

• - Exceptional capability to manage multiple tasks in a fast-paced and constantly changing environment.

• - Proven ability to collaborate effectively within a matrix and/or cross-functional setting.

• - Self-motivated and organized, with the ability to work independently for extended periods.

🏝️ Benefits

• TBC depending on location.