This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Associate Director, Medical Safety (Scientist) in the United States.
This role sits at the core of global pharmacovigilance and medical safety strategy, ensuring the continuous monitoring and evaluation of product safety across clinical and post-marketing stages. You will play a key part in safeguarding patient health by leading signal detection, risk management, and aggregate safety reporting activities for innovative therapies in complex therapeutic areas. Acting as both a scientific expert and cross-functional leader, you will collaborate closely with medical safety physicians, regulatory teams, and clinical development stakeholders. The position also involves representing medical safety in high-level governance forums and contributing to global regulatory submissions. In a highly regulated and science-driven environment, you will help shape safety strategy, improve processes, and ensure inspection readiness. This is a high-impact role for someone who thrives at the intersection of science, compliance, and strategic decision-making.
Accountabilities:- Lead and coordinate cross-functional Safety Management Teams, driving end-to-end safety strategy for assigned products and programs.
- Oversee signal detection, evaluation, prioritization, and communication, ensuring timely identification of safety concerns and appropriate actions.
- Ensure compliance with global pharmacovigilance regulations, maintaining inspection readiness and up-to-date safety governance processes.
- Contribute to and lead aggregate safety reporting activities, including DSURs, PBRERs, and PADERs, ensuring high scientific and regulatory standards.
- Develop and author risk management plans and safety evaluation documents, including labeling update recommendations when required.
- Provide strategic input into regulatory submissions, responses, and safety sections of global development programs.
- Represent Medical Safety in internal and external governance forums, including safety boards and partner meetings.
- Mentor and support junior team members, fostering capability building within the Medical Safety organization.
Requirements:
- Minimum of 6 years of experience in drug safety or pharmacovigilance, including at least 4 years focused on safety surveillance and risk management.
- Strong understanding of global pharmacovigilance regulations, signal management methodologies, and aggregate safety reporting requirements.
- Experience in authoring and reviewing safety documents such as DSURs, PBRERs, risk management plans, and evaluation reports.
- Ability to independently conduct literature and safety database searches and interpret clinical safety data.
- Excellent scientific writing, communication, and stakeholder management skills across interdisciplinary teams.
- Solid knowledge of medical terminology, clinical development processes, and safety data systems including MedDRA.
- Degree in life sciences or related scientific discipline such as pharmacy, nursing, biology, or equivalent advanced qualification.
- Demonstrated leadership ability with experience mentoring or guiding junior colleagues in a regulated environment.
Benefits:
- Competitive base salary range between 156,000 and 234,000 USD depending on experience and qualifications.
- Eligibility for annual performance-based bonus and potential long-term equity incentives.
- Comprehensive healthcare coverage including medical, dental, and vision insurance.
- Retirement savings plan such as a 401k with company participation.
- Flexible paid vacation policy supporting work-life balance.
- Remote work flexibility depending on role requirements.
- Access to professional development opportunities in a global, science-driven organization.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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