Job details

Pharmacovigilance Associate

Get a free resume review

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

$70000 / YEARLY (est.)

min

max

$60000K

$80000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Pharmacovigilance Associate, Clinigen

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!

Frequently Asked Questions (FAQs) for Pharmacovigilance Associate Role at Clinigen

What are the main responsibilities of a Pharmacovigilance Associate at [Company Name]?

As a Pharmacovigilance Associate at [Company Name], your primary responsibilities will include assessing and processing serious adverse events and Individual Case Safety Reports (ICSRs), ensuring compliance with regulatory standards. You'll play a crucial role in maintaining client relations, managing data inquiries, and performing quality control on cases in our Global Drug Safety database. Your proactive support for both internal operations and client-specific needs will be essential in fostering a successful partnership.