Pv Specialist, Benefit Risk

Company Description
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

**Job Description**:
The PV Specialist, Benefit Risk will support the activities in Benefit Risk group in ensuring that day to day operational activities are completed.

The PV Specialist, Benefit Risk will be expected to be professional and diligent and shall liaise with Senior members in the team on any issues. The PV Specialist, Benefit Risk is also expected to lead by example and ensure quality standards are upheld within the company.

The activities listed may not always be undertaken by the PV Specialist, Benefit Risk, however these activities are within the remit of the role:

- Literature screening activities (set-up of literature screening strategies, literature databases’ activities, assessment of the results)
- Preparation, review and submission of Aggregate Reports (PSUR/ DSUR/ PADER/ ACO)
- Authoring/ updating of Risk Management Plans (RMPs)
- Creation/ maintenance of Company Core Data Sheets (CCDSs) and creation of supporting documentation (e.g. Clinical Overview (CO), Clinical Expert Statement (CES), etc.)
- Assistance with compilation of safety variations, if required
- Assisting with responding to regulatory authority queries
- Compilation and presentation of submission metrics for aggregate reports
- Authoring of signal assessment reports
- Assisting with scheduling and forecasting of aggregate reports and signal management activities
- Assist senior team members and management in implementing and improving processes
- Communication with internal and external stakeholders
- Training/ mentoring new team members as necessary
- Participating in internal/ external audits/ inspections as SME, if required Assisting QMS team with deviations/ CAPAs, as assigned
- Acting as Client Manager and back-up for clients and colleagues respectively, if required
- Assisting with any other ad-hoc requests, as necessary

**Qualifications**:

- Life sciences degree
- 2+ years’ experience in Pharmacovigilance
- A thorough foundation in pharmacovigilance, ideally having experience in various aspects of pharmacovigilance
- Significant experience in literature screening activities;
- Sufficient experience authoring and reviewing aggregate reports, including PSURs, PADERs, DSURs, ACOs in line with applicable templates and guidance
- Experience in authoring and updating RMPs in line with applicable template and guidelines
- Experience managing CCDSs, including the creation and update of CCDSs, along with creating supporting documentation (e.g. CO, CES, etc.)
- Knowledge of regulatory safety variation processes
- Knowledge of signal detection methodologies and modalities, and experience in Knowledge in other pharmacovigilance processes, ability to author/ update SOPs or WINs, to identify and author deviations/CAPAs
- Knowledge of audit/ inspection process and participative experience
- Demonstrable ability to analyze and quantify large volumes of data in a concise and scientific manner, in keeping with regulatory deadlines
- Keen organizational skills, with the ability to manage a dynamic workload effectively
- Sound communication skills

Additional Information
- We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.