Associate Director - Pharmacovigilance Operations

Actalent

Full-time - Senior

10,001+ employees

Administrative and Support Services

About the position

The Associate Director of Pharmacovigilance Operations at Actalent is responsible for the development and execution of global pharmacovigilance processes and deliverables. This role involves supporting ongoing clinical trials, vendor oversight, and ensuring compliance with regulatory standards. The position requires collaboration with various stakeholders to maintain harmonized operations and high standards in pharmacovigilance activities, both in clinical trials and post-marketing support.

Responsibilities

• Develop and execute global pharmacovigilance processes and deliverables.
• Support ongoing clinical trials and vendor oversight.
• Partner with key stakeholders to ensure harmonized operations of global pharmacovigilance activities.
• Lead and review safety sections of various regulatory documents to ensure compliance.
• Oversee CROs responsible for DSPV-SAE reporting and generation of safety reports.
• Collaborate in regulatory inspection preparedness and audit readiness.
• Assist in safety database setup and performance, including validation checks.
• Participate in DSPV or clinical audits of CROs/vendors.
• Collaborate in related biometrics processes and perform reviews as needed.
• Provide DSPV advice and guidance to other functional groups.
• Interface with other functional groups to ensure harmonization of processes and data collection.
• Attend relevant meetings with CROs/vendors and DMCs.

Requirements

• Completion of an undergraduate degree in a scientific discipline (BS/BSc/Nursing); a graduate degree is an asset (PharmD, MS, NP, MD).
• A minimum of 8+ years of related job experience in pharmacovigilance or drug safety.
• Knowledge of FDA, EMA, and other regulatory adverse event reporting regulations.
• Excellent oral and written communication skills.
• Strong collaboration and leadership skills.
• Expert scientific knowledge and organizational skills.
• Strategic thinking and influencing skills.
• Experience in vendor oversight and stakeholder management.
• Medical and technical writing experience.
• Ability to work in a complex and evolving environment.
• Willingness to travel up to 10% for company meetings.

Benefits

• Competitive pay range of $90.00 - $100.00 per hour.