Assoc Director, Patient Safety RM

职位描述

The Associate Director, Patient Safety provides strategic pharmacovigilance leadership for one or more products, compounds, or indications across the development and/or post marketing lifecycle. This role contributes safety expertise to ensure continuous evaluation of benefit–risk profiles, regulatory compliance, and patient safety, while serving as a key Patient Safety representative on cross functional teams.
The Associate Director operates with a high level of autonomy, partnering across functions to support product development, lifecycle management, and post authorization safety activities.

Key Responsibilities

• Provide scientific input into pharmacovigilance activities, including safety surveillance, signal detection and evaluation, and benefit–risk assessments for assigned products and assisting with pharmacovigilance activities for other products when needed.

• Contribute to the development and execution of safety strategies across the product lifecycle, from clinical development through post‑marketing.

• Provide input into aggregate safety reports (e.g., PSURs/PBRERs, DSURs), regulatory submissions, and responses to health authority inquiries.

• Support risk management activities, including Risk Management Plans, risk minimization measures, and safety‑related labeling updates.

• Provide safety leadership and review of clinical study protocols, amendments, and study‑related documents.

• Serve, where applicable, as a medical monitor for post‑authorization, Phase 4, or observational studies, including investigator‑initiated and collaborative research.

• Represent Patient Safety on cross‑functional teams, collaborating with Clinical Development, Regulatory Affairs, Medical Affairs, RWE/HEOR, and other functions.

• Ensure pharmacovigilance activities are conducted in compliance with global regulations, internal SOPs, and quality standards.

• Contribute to inspection readiness, process improvement initiatives, and the ongoing enhancement of Patient Safety operating models.

• Build effective working relationships and provide thoughtful safety input to internal stakeholders to support patient‑centric decision‑making.

Basic Qualifications

• Advanced degree in a scientific or medical discipline (e.g., MD, PharmD, PhD, or equivalent).

• Relevant experience in pharmacovigilance / patient safety within the pharmaceutical or biotechnology industry.

• Working knowledge of global pharmacovigilance regulations and aggregate safety reporting requirements.

• Demonstrated ability to evaluate safety data, apply clinical judgment, and communicate benefit–risk considerations.

• Experience working effectively in cross‑functional, matrix environments.

Preferred Qualifications

• Experience supporting safety oversight for products across multiple stages of the development or post‑marketing lifecycle.

• Prior involvement in safety signal evaluation, risk management activities, and regulatory interactions.

• Strong written and verbal communication skills, with the ability to present complex safety information to diverse stakeholders.

• Ability to manage multiple priorities and products concurrently in a fast‑paced environment.