Senior Pharmacovigilance Associate X2

As a PV Officer 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; 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**:

- Assess and process serious adverse events (SAEs) and Individual Case Safety Reports (ICSRs) into the Global Drug Safety database and carry out QC.
- Working on E2B/R3 format reporting and Case Finalization; reading error messages and taking steps to correct cases as a result of negative acknowledgments.
- Investigating cases of non-compliance of SAEs/ICSRs and supporting development of non-conformances and corrective and preventative actions.
- Support quality and efficiency strategies within the organisation
- Support the Company with bid defence meetings
- Develop PV medical training presentations. deliver training and mentor PV staff as well as support with relevant SOP authoring.
- Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits
- Prepare relevant cases for submission and sending to the relevant Regulatory Authorities
- Support Safety Evaluation and Risk Management (SERM) team with aggregate PV data analysis for signal detection/aggregate reporting purposes
- Performing Literature Article reviews
- Support the collation and dissemination of quality and compliance metrics for pharmacovigilance and medical information activities

**Requirements**:

- Healthcare Professional qualification or equivalent of a Batchelor of Science (BSc) degree
- Experience in PV with demonstrable understanding of PV processes and requirements
- 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 organisational and prioritisation 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

**Benefits**
- 27 days holiday plus 8 bank holidays
- Pension contributions 4.5% matched
- Life assurance 4 x annual salary
- Flexible Benefits Platform with £25/month Company contribution
- Annual salary review
- Independent financial advice service
- Enhanced Employee Assistance Programme
- Shopping discounts with retailers
- Long service awards
- Recognition scheme & employee of the year awards