Propharma, the world's largest Research Consulting Organization (RCO), is hiring a Pharmacovigilance Safety Scientist in India. This role requires a life science degree and at least three years of experience in pharmacovigilance. If you have a passion for ensuring patient safety and regulatory compliance, this could be the perfect opportunity for you.
About Propharma
For over 20 years, Propharma has been dedicated to improving patient health and wellness. We provide comprehensive consulting solutions across the biotech, med device, and pharmaceutical industries. Our services span regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology. By partnering with clients through an advise-build-operate model, we support the entire product lifecycle, de-risking and accelerating drug and device programs.
Job Overview: Pharmacovigilance Safety Scientist
As a Pharmacovigilance (PV) Safety Scientist at Propharma, you will support the Benefit-Risk group, ensuring that operational activities are efficiently completed. You will coordinate with the Director and management team, uphold quality standards, and mentor new team members.
Key Responsibilities
- 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.
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Propharma Hiring Pharmacovigilance Safety Scientist[/caption]
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
Experience Requirements
- 3 years' experience in Pharmacovigilance, preferably medical writing roles.
How to Apply
If you meet the qualifications and are excited about this opportunity, please apply online at
Propharma Careers.
https://pharmastuff.org.in/job/propharma-hiring-pharmacovigilance-safety-scientist
