DIRECTOR SAFETY SCIENCES

Alpha Clinical; North Carolina; On-site; USD 120,000 - 160,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Director of Safety Sciences to oversee pre- and post-marketing safety surveillance activities. The ideal candidate will have at least 7 years of experience in the pharma or biotech industry, including over 4 years in pharmacovigilance. Responsibilities include managing safety data, leading regulatory interactions, and preparing detailed safety reports. This role demands superior medical writing skills and proficiency in data analysis. Competitive compensation offered.

Qualifications

• Minimum 7 years of experience in the pharma/biotech industry.
• 4+ years in pharmacovigilance or drug safety.
• Experience with BLA/MAA submissions.

Responsibilities

• Manage pre- and post-marketing safety surveillance activities.
• Lead signal detection and evaluate safety risks.
• Prepare aggregate safety reports for regulatory documentation.

Skills

Medical writing

Data analysis

Pharmacovigilance

Risk assessment

Clinical data interpretation

Education

Advanced degree in healthcare (MD, PharmD, PhD, RN, or BSN)

Tools

Data analysis software

Job description

Overview

ACDL is looking for a Director of Safety Sciences to manage pre‑ and post‑marketing safety surveillance activities for investigational and marketed products, ensuring compliance with global pharmacovigilance regulations and company procedures.

Responsibilities

• Manage all pre‑ and post‑marketing safety surveillance activities for assigned products throughout the product lifecycle in compliance with ICH, FDA, EMA, and GVP guidelines.
• Lead and provide input on the Company’s Global Safety Strategy, ensuring continuous review and assessment of safety data.
• Provide pharmacovigilance and drug safety leadership for clinical development programs.
• Participate in regulatory interactions worldwide (FDA, EMA) and provide medical review of individual case safety reports.
• Lead and contribute to the preparation of medical/scientific assessments of safety data for all regulatory and scientific documents.
• Direct creation and maintenance of the company’s Core Safety Information and implement CCSI in all reference safety information.
• Lead signal detection activities, evaluate and validate safety signals, and communicate safety risk assessments.
• Prepare and participate in Safety Management Team, Benefit Risk Assessment Team, and other product forums.
• Lead preparation of aggregate safety reports (PSUR, PBRER, PADER, DSUR, etc.) and ensure safety profiles are reflected across regulatory documents.
• Lead risk‑benefit evaluations and prepare RMPs for assigned products.
• Participate in inspection readiness activities, internal audits, and external inspections.
• Maintain knowledge of disease states and stay informed of new PV/safety regulations and guidance.

Qualifications

• Advanced degree in a healthcare field (MD, PharmD, PhD, RN, or BSN).
• Minimum 7 years of experience in the pharma/biotech industry, with 4+ years in pharmacovigilance or drug safety.
• Superior medical writing skills, particularly for Safety Signal, ISS, RMP, DSUR, PSUR, PBRER.
• Successful experience with BLA/MAA submissions and interactions with FDA, EMA, and other regulatory authorities.
• Proficiency in data analysis software and solid experience interpreting clinical data.
• Experience developing and implementing risk mitigation and assessment strategies.
• Expertise in generating safety data presentations for safety meetings.
• Expertise in medical assessment of an ICSR, including causality assessment.