Senior Scientist, Global Drug Safety & Pharmacovigilance

Location: Plainsboro

Job Description

Target Pay Rate: 63-73/hr salary will be commensurate with experience

Lead planning and execution of assigned processes/projects (e.g. PMS activities including resource estimation; PV reviews; safety management and review planning)
Perform regular trending of quality results/observations to identify potential trends or issues and propose long-term strategies for quality improvement or issue resolution
Perform investigation of deviations and monitoring of Corrective Actions/Preventive Actions (CAPAs) relating to non-compliance issues and findings
Support development & review of working instructions, SOPs, and job aids for PV systems; and training of end-users as applicable (e.g. PMS education)
Develop relevant regulatory reports/documents and safety materials (e.g. patient guidance document)
Provide oversight to vendor activities within area (e.g. data management, query confirmation)
Participate in implementation and upgrade of PV systems and solutions (e.g. validation documents review, User Acceptance Testing(UAT), E2B testing with regulatory agents and business partners)
Proactively guide and collaborate with cross-functional teams as a subject matter expert

Responsibilities:
We would like to engage a contractor medical writer under a task-based model to support our aggregate safety reporting activities. The immediate priority is technical quality control (QC) of aggregate safety reports, including PSURs/PBRERs, DSURs, RMP updates, and related deliverables, ensuring consistency, accuracy, regulatory compliance, and scientific integrity. In addition to QC, this contractor would provide project management support for aggregate reports by maintaining reporting calendars, tracking milestones, coordinating cross-functional inputs, and helping ensure on-time, inspection-ready submissions.

The role would also provide flexible support to our internal medical writer, including assistance with drafting, document updates, and other aggregate deliverable needs, depending on workload and priorities as needed. The engagement would be structured around defined deliverables rather than a full-time position, allowing scalable support aligned with reporting cycles.
Since this is a contractor role, the role as confirmed by HR can be remote but it would be nice if the contractor can come to the office occasionally.

Aggregate Safety Report (ASR) Project Management and Medical Writing

- Lead project management activities for PSURs/PBRERs, DSURs, RMP updates, and other aggregate deliverables.
- Maintain reporting calendars, track milestones, and facilitate cross-functional collaboration to ensure on-time, inspection-ready reports.
- Anticipate risks, identify bottlenecks, and drive efficient resolution.
- Author (medically write) key sections of ASRs, Risk Management Plans (RMPs), signal evaluation reports, health authority responses, and risk-benefit summaries.
- Synthesize complex data into clear, scientifically robust narratives tailored to regulatory expectations.
- Perform QC of deliverables to ensure consistency, accuracy, and scientific integrity.
- Own and maintain ASR processes, SOPs, templates, guidance documents, and training materials.
- Ensure all documentation is updated to reflect evolving global regulatory requirements.
- Identify and implement process improvements that enhance efficiency and compliance.

Equal Opportunity

Employer:

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate.

We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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