Specialist, Drug Safety

Responsibilities

• Execute local pharmacovigilance processes, ensuring alignment with applicable regulations and global standards.
• Manage adverse event cases end-to-end (intake, assessment, follow-up, and reporting).
• Coordinate aggregate safety reports and support post-marketing safety monitoring programs.
• Participate in audits and inspections, including preparation, documentation support, and CAPA follow-up.
• Contribute to continuous improvement through the development and maintenance of local PV procedures.
• Support implementation of risk minimization measures and Risk Management Plans (RMPs), as applicable.
• Act as a local PV subject matter expert, providing guidance to internal teams and participating in cross-functional initiatives.
• Ensure compliance with activities such as literature review, health authority monitoring, and document management.
• Support business continuity plans and training activities.
• Profile:
• Professional with experience in pharmacovigilance, strong focus on quality and compliance, able to work independently, influence cross-functional teams, and maintain a strong patient safety mindset.
• Required Skills:
• Preferred Skills:
• Current Employees apply HERE
• Current Contingent Workers apply HERE
• Search Firm Representatives Please Read Carefully
• Employee Status:
• Regular
• Relocation:
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Hybrid
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Job Posting End Date:
• 06/13/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Benefits

Additional Information

Job Description Pharmacovigilance Specialist We are looking for a Pharmacovigilance Specialist responsible for executing and ensuring local PV activities, guaranteeing compliance with applicable regulations, as well as company policies and procedures. This role operates with a high level of autonomy in the day-to-day management of safety activities and works closely with internal teams, business partners, and regulatory authorities.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Merck? Share your experience