Director, Aggregate Safety Reporting & Pharmacovigilance Medical Writing

AllSTEM Connections is seeking a Director, Aggregate Safety Reporting & Pharmacovigilance Medical Writing

to work hybrid onsite in Plainsboro, NJ.

This is a six-month contract position. Possible extension/temp-to-hire.

Hourly rate is up to $140/hour.

SUMMARY:

This role, Aggregate Safety Report (ASR) Project Management and Pharmacovigilance Medical Writer, leads the planning, project management, scientific authoring, and delivery of aggregate safety reports and other pharmacovigilance-related regulatory documents.

The position requires advanced scientific writing expertise, strong project management capabilities, and the ability to integrate and critically evaluate complex safety evidence to develop scientifically sound conclusions and consistent regulatory messaging. The individual will lead cross-functional authoring activities, manage document timelines and reviews, ensure high-quality and inspection-ready deliverables, and drive continuous improvement of medical writing processes.

RESPONSIBILITIES

• Lead the planning, project management, and delivery of aggregate safety reports and other pharmacovigilance documents, including DSURs, PSURs/PBRERs, PADERs/PAERs, Risk Management Plans, signal evaluation reports, and safety topic assessments.
• Independently author complete documents or substantive sections of complex safety and regulatory deliverables, taking ownership from initial evidence review and document strategy through finalization and approval.
• Integrate and critically evaluate safety evidence from clinical trials, spontaneous reports, published literature, nonclinical studies, and other relevant sources to characterize safety findings, assess clinical significance, and determine implications for the product safety profile.
• Develop integrated safety assessments and benefit-risk evaluations, addressing temporal relationships, alternative etiologies, confounding factors, class effects, risk factors, data limitations, and areas of uncertainty.
• Translate complex medical and scientific concepts, including disease biology, mechanisms of action, adverse event pathophysiology, and potential causal relationships, into clear, accurate, and scientifically balanced regulatory narratives.
• Develop document strategies, structures, key scientific messages, and evidence-based conclusions, ensuring appropriate medical and cross-functional alignment and consistency across pharmacovigilance and regulatory deliverables.
• Lead project management activities for aggregate safety reporting and other pharmacovigilance deliverables, including reporting calendars, timelines, milestones, resource planning, cross-functional reviews, approvals, and submission readiness.
• Proactively identify project risks, bottlenecks, content gaps, and conflicting reviewer feedback, driving resolution while maintaining scientific accuracy, consistency, traceability, and inspection readiness.
• Collaborate with Safety Physicians, Safety Scientists, Regulatory Affairs, Clinical Development, Biostatistics, and other subject matter experts to resolve scientific questions and align source evidence, analyses, conclusions, and regulatory positions.
• Prepare and review safety content for regulatory submissions, investigator's brochures, safety communications, health authority responses, governance materials, briefing documents, presentations, and internal or external safety inquiries.
• Oversee medical writing activities performed by internal partners, CROs, and external vendors, establishing clear expectations, responsibilities, timelines, and quality standards.
• Provide medical writing leadership and strategic guidance to cross-functional teams, including serving as a compound lead writer or medical writing representative on relevant development and submission teams.
• Perform scientific and quality reviews to ensure medical accuracy, data consistency, appropriate referencing, traceability, and compliance with applicable regulatory requirements and internal standards.
• Develop, maintain, and improve aggregate safety reporting and pharmacovigilance writing processes, including SOPs, templates, guidance documents, and training materials.
• Identify and implement improvements in project management, evidence synthesis, document development, and review workflows to enhance efficiency, quality, consistency, and compliance.
• Represent Medical Writing in relevant cross-functional governance forums, project teams, regulatory submission teams, and operational committees.

QUALIFICATIONS & REQUIREMENTS

• Advanced degree in medicine, pharmacy, life sciences, or a related discipline (e.g., MD, PharmD, PhD), with a strong foundation in clinical research, medical science, and safety data interpretation.
• Minimum 10 years of relevant experience in pharmacovigilance, clinical safety, regulatory medical writing, or a related pharmaceutical or biotechnology field.
• Extensive experience independently authoring complex safety documents and leading cross-functional authoring activities for major regulatory submissions and post-approval requirements.
• Demonstrated experience leading safety authoring for marketing authorization and post-approval submissions, including document strategy, scientific content development, review, and timely delivery.
• Proven ability to independently author and critically review key safety and regulatory deliverables, including DSURs, PSURs/PBRERs, PADERs/PAERs, Risk Management Plans, signal evaluations, health authority responses, Summaries of Clinical Safety, Clinical Overviews, Integrated Summaries of Safety, CSR safety sections, and patient narratives.
• Demonstrated expertise in integrated safety assessments and benefit-risk evaluations, synthesizing clinical trial, post-marketing, literature, and other relevant evidence into scientifically sound conclusions and regulatory positions.
• Strong understanding of global health authority expectations, CTD safety content, and pharmacovigilance requirements, with experience supporting regulatory submissions and health authority interactions.
• Strong scientific judgment and ability to interpret complex clinical and safety data, identify material findings and evidence gaps, reconcile conflicting evidence, communicate uncertainty, and develop clear, persuasive medical narratives and recommendations.
• Proven ability to manage multiple concurrent deliverables and cross-functional reviews, including complex timelines, dependencies, resource requirements, and competing priorities.
• Excellent scientific writing, critical review, executive communication, and cross-functional leadership skills, with the ability to influence senior stakeholders and collaborate across Safety, Regulatory Affairs, Clinical Development, Biostatistics, and Medical Writing.
• Experience developing authoring standards, templates, SOPs, training programs, and process improvements to maintain consistent quality and regulatory compliance.
• Oncology development and submission experience preferred, including familiarity with complex treatment settings, combination therapies, and interpretation of safety findings in patients with advanced disease and significant comorbidities.

ADDITIONAL POSITION DETAILS

• Work Arrangement: Hybrid, onsite 2–3 days per week.
• Anticipated Start: Targeting a start after the new year, although a December start may be considered depending on candidate availability and project timing. Requisition start date may be adjusted accordingly.
• Interview Process: Two rounds of interviews, including hiring manager and members of the team