Job Description

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
The Pharmacovigilance (PV) Safety Scientist supports the activities in the Benefit Risk group by ensuring that day to day operational activities are completed.

The PV Safety Scientist is expected to be professional and diligent and

liaises with Director and management group members within the team on any issues, as well as coordinate the work with the Senior PV Safety Scientists. The PV Safety Scientist is also expected to lead by example and

ensures quality standards are upheld within the company.
Essential Functions:• Coordination and performance of Literature screening activities (set- up of literature screening strategies, literature databases' activities, assessment of the results), acting as SME.
• Coordination and performance of preparation, review, and submission of Aggregate Reports (PSUR/ DSUR/ PADER/ ACO), acting as SME, (as applicable).
• Coordination and performance regarding Authoring/ updating of Risk Management Plans (RMPs), acting as SME (as applicable).
• Compilation and presentation of submission metrics for aggregate reports.
• Coordination and authoring of signal assessment reports, acting as SME.
• Assists with scheduling and forecasting of aggregate reports and signal management activities.
• Communication with internal and external stakeholders.
• Training/ mentoring new team members.
• Participates in internal/ external audits/ inspections as SME, if required, assisting QMS team with deviations/ CAPAs, as assigned.
• Supporting Project Managers, if required.
• Assisting with any other ad-hoc requests, as necessary.In coordination with the management group, assuming the responsibility for:
• Maintenance of Company Core Data Sheets (CCDSs).
• Assistance with a compilation of safety variations, if required.
• Coordination and responding to regulatory authority queries.


Necessary Skills and Abilities:• A thorough knowledge foundation in pharmacovigilance, ideally having clinical experience in various aspects of pharmacovigilance.
• Significant experience in literature screening activities.
• Significant experience authoring and reviewing aggregate reports, including PSURs, PADERs, DSURs, ACOs in line with applicable templates and guidance.
• Significant experience in authoring and updating RMPs in line with applicable template and guidelines.
• Significant knowledge of signal detection methodologies and modalities, and experience in authoring signal assessment reports.
• Preferably:
• Experience managing CCDSs, including the creation and update of CCDSs.
• Knowledge of regulatory safety variation processes.
• Knowledge of other pharmacovigilance processes, ability to author/ update SOPs or Working instructions, to identify and author deviations/CAPAs.
• Knowledge of audit/ inspection process and participative experience.
• Demonstrable ability to analyze and quantify large volumes of data concisely and scientifically, in keeping with regulatory deadlines.
• Keen organizational skills, with the ability to manage a dynamic workload effectively.
• Sound communication skills.


Educational Requirements:• Life science degree.


Experience Requirements:• 3 years' experience in Pharmacovigilance, preferably medical writing roles.

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.
•ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting. •