Pharmacovigilance Associate
As a PV Associate you will work within the Pharmacovigilance Operations 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.
Key Responsibilities:
For the Company
- 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.
- 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
To be successful in this role you'll need:
- Healthcare Professional qualification or equivalent of a Batchelor of Science (BSc) degree
- 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
- 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 organised, with the ability to work unsupervised for periods of time
- Excellent analytical thinking, with the ability to evaluate and present complex safety data
- applying sound judgement.
Average salary estimate
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Are you ready to make a significant impact in the world of pharmaceuticals? As a Pharmacovigilance Associate with our dynamic team at [Company Name], you'll be at the forefront of safety and compliance for some of the most reputable pharmaceutical clients globally. Your day-to-day will include collaborating with an enthusiastic group of professionals focused on processing and analyzing vital safety information for pharmaceutical products. You'll assess serious adverse events and Individual Case Safety Reports, ensuring that every piece of data is meticulously compiled into our Global Drug Safety database. You’ll also support various quality initiatives, assist in regulatory preparedness, and maintain communication with clients, all while fostering a culture of teamwork and excellence. This role isn’t just about maintaining standards; it's about pushing the envelope and contributing to the betterment of pharmacovigilance operations. Your skills in relationship-building, analytical thinking, and organization will help you thrive, especially as you manage client inquiries and oversee case processing. We’re looking for someone who is self-motivated, detail-oriented, and ready to tackle challenges in a fast-paced environment. If you are passionate about safety and compliance in the healthcare sector and seek a role that values high-quality work while nurturing a collaborative environment, we want to hear from you. Join us and help redefine the future of pharmacovigilance!
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