Associate Director, Pharmacovigilance Operations

About PTC Therapeutics

PTC Therapeutics is a globally recognized biopharmaceutical company with over 25 years dedicated to improving the lives of children and adults affected by rare diseases. Our organization fosters an inclusive environment where every team member is valued, respected, and empowered to contribute fully.

Role Overview

The Associate Director, Pharmacovigilance Operations will oversee all pharmacovigilance operational activities both performed internally and outsourced. This includes management of the collection, processing, assessment, monitoring, and follow-up of safety data from multiple sources, such as clinical trials and post-marketing surveillance. The position ensures adherence to all applicable pharmacovigilance guidelines and regulations while collaborating across departments and with external partners, including oversight of the Pharmacovigilance vendor.

Key Responsibilities

• Lead and actively contribute to the creation and maintenance of a comprehensive safety reporting system aligned with current regulatory standards, managing PV vendor performance and case workflow.
• Conduct quality reviews of individual case safety reports (ICSRs) to ensure regulatory compliance and timeliness.
• Provide training support to the PV vendor regarding new products and regulatory obligations.
• Assist in the setup and implementation of pharmacovigilance measures for new clinical studies and post-authorization safety programs.
• Review and provide input on PV vendor operational documents including operational plans and specific work instructions.
• Oversee safety database configurations ensuring regulatory compliance and operational suitability.
• Guarantee the quality, completeness, and punctual delivery of all safety database outputs such as routine oversight reports, aggregate data, and responses to health authority queries.
• Support the development and execution of PTC's pharmacovigilance strategic business continuity plans.
• Develop and refine ICSR-related processes and participate in the enhancement and upkeep of related Standard Operating Procedures (SOPs).
• Maintain and archive both electronic and physical drug safety documentation relevant to ICSR management.
• Fulfill additional duties and management tasks as assigned.

Required Qualifications and Skills

• Bachelor’s degree in Biological Sciences, Pharmacy, PharmD, or BSN/RN preferred.
• Minimum seven years of progressively responsible pharmacovigilance experience in pharmaceutical or biotechnology settings, including at least three years in a leadership role for pharmacovigilance operations.
• Expertise in FDA, European Union, and ICH pharmacovigilance regulations and guidelines.
• Extensive practical knowledge of MedDRA coding and adverse event (AE) and serious adverse event (SAE) processing in the pharmaceutical industry.
• Hands-on experience with the Argus Safety database.
• Proven ability to improve departmental processes to enhance efficiency and quality in safety reporting.
• Strong influencing, verbal, and written communication skills.
• Highly skilled in Microsoft Office applications.
• Ability to work both independently and collaboratively in a dynamic, matrixed team environment.
• Analytical mindset with problem-solving capabilities and flexibility to adapt to shifting priorities and deadlines.
• Excellent organizational and multi-project prioritization skills.
• Experience with electronic document management systems (eDMS) and WHO Drug Dictionary (WHODD) for drug coding.
• Understanding of safety database administration, configuration, and data management.
• Travel requirement up to 10%.

Additional Information

This position is primarily office or remote-based and does not require physical exertion beyond typical office work.

Equal Employment Opportunity Statement

PTC Therapeutics is an equal opportunity employer. We embrace diversity and welcome applications from candidates of any race, color, national origin, gender, age, disability, religion, sexual orientation, gender identity and expression, pregnancy, veteran status, or any other category protected by applicable laws. We strive to provide fair treatment to all applicants and avoid discrimination in our hiring process.