Associate Director, Pharmacovigilance Scientist

The Steely Group; Massachusetts; Hybrid; USD 170,000 - 230,000; Full time

Job summary

The Steely Group is seeking an Associate Director, Pharmacovigilance Scientist to lead PV activities for assigned products, partnering with Safety Physicians and cross-functional teams. This role emphasizes data analysis, signal management, and regulatory submissions to support NDA/MAA filings.

The candidate should bring 5–6 years PV experience, advanced clinical or scientific degrees, and strong communication skills to mentor juniors and drive safety science initiatives across programs.

Qualifications

• Minimum 5-6 years PV experience with leadership exposure.
• Experience in analysis and interpretation of medical and scientific data.
• Experience leading signal management activities and aggregate reports.

Responsibilities

• Serves as lead PV Scientist for assigned product(s) – 60%.
• Conducts signal detection, evaluation, and management with data coordination and analysis.
• Leads and manages DSURs, PADERs, PBRERs preparation and reviews.
• Leads and manages risk management plans.
• Performs literature surveillance and prepares safety governance materials.
• Contributes to safety-related regulatory queries and analyses.
• Contributes to safety analyses for regulatory filings (NDAs/MAAs).
• Supports inspection readiness as SME during audits/inspections.
• Leads strategic innovations and process improvements across products.

Skills

PV data analysis

Lead signal management

Regulatory submissions

Communication

Mentorship

Education

Advanced degree (PharmD, MD, PhD, MPH)

Tools

Argus Safety

MS Office

Job description

The Associate Director, Pharmacovigilance Scientist plays a critical role in safety data analyses for assigned investigational and/or marketed product(s) in partnership with the Safety Physician. This individual also serves as a subject matter expert for the PV Sciences group, contributing to strategic initiatives in collaboration with key stakeholders. The Associate Director, Pharmacovigilance Scientist is expected to be equally effective in working collaboratively and independently. She/he will be responsible for leading and/or contributing to activities such as signal management, aggregate reports, RMP development, ad hoc safety query responses, literature surveillance, and safety analyses for regulatory submissions (NDA, MAA, etc.). For investigational products, this role may also encompass contributions to IB/RSIs, ICFs, SMPs, DMC materials, coding reviews, and safety analyses for CSRs, as applicable. The Associate Director, Pharmacovigilance Scientist will also contribute to process improvement initiatives, lead strategic innovations, and manage/mentor others, as opportunities permit.

Key Responsibilities

• Serves as lead PV Scientist for assigned product(s) – 60%
• Conducts signal detection, evaluation, and management, including data coordination, analysis, presentation, and documentation
• Leads and manages the planning, preparation, writing, and review of aggregate safety reports (DSURs, PADERs, PBRERs)
• Leads and manages the planning, preparation, writing, and review of risk management plans
• Performs literature surveillance
• Prepares materials for safety governance meetings
• Contributes to safety-related regulatory queries, including data coordination and analysis
• Contributes to relevant sections of key documents (IB/RSIs, CCDS/labels, ICF, DMC materials, coding reviews, CSRs, etc., as applicable)
• Contributes to safety analyses associated with regulatory filings (e.g., New Drug Applications or Marketing Authorization Applications)
• Supports team in proactively maintaining inspection readiness and serves as a subject matter expert in the event of an inspection

Other functional and cross-functional initiatives – 25%

• Leads strategic innovations (streamlines processes, evaluates implementation of new technology and resources, etc.)
• Conducts impact assessments (e.g., updates to regulations, etc.)
• Leads process improvement initiatives and consistency of cross-product processes
• Conducts functional trainings and shares knowledge with the team
• Supports deliverables for other products, where needed

Management and mentorship – 15%

• Manages, mentors, and trains junior members of the team
• Supports individual development of direct reports

Requirements/Qualifications

• Minimum 5-6 years PV experience, including a minimum of 3-4 years in a PV Scientist or similar role
• Advanced degree (PharmD, RN, MD, PhD, MPH, NP, MS)
• Demonstrated experience in analysis and interpretation of medical and scientific data, including experience leading signal management activities and the preparation and authoring of aggregate reports in both post-marketing and clinical trials
• Excellent oral and written communication skills, including the ability to effectively communicate key considerations and decision points
• Detail-oriented with ability to think critically, prioritize tasks, and function independently
• Expert knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations
• Proven track record in preparing and reviewing regulatory safety documents, including NDAs/MAAs and RMPs
• Prior experience serving as an SME in audits and/or inspections

Preferred Capabilities

• Demonstrated experience in various therapeutic areas (e.g., oncology, CNS, etc.)
• Expert proficiency with pharmacovigilance databases and relevant coding dictionaries
• Expert knowledge/proficiency with Microsoft Office Suite and Argus Safety systems