Associate Director, Pharmacovigilance Operations (Contract)

Job Description Summary

The Associate Director, Pharmacovigilance Operations oversees Pharmacovigilance Operations activities, both internally supported and outsourced, including the collection, processing, assessment, monitoring and follow up of all types of safety information from various sources, including clinical trials and post marketing, and any other PV Vendor deliverable. The incumbent ensures all relevant Pharmacovigilance guidelines and regulations are adhered to and works cross functionally with internal departments and external resources on ICSR and safety database related matters. This includes providing strategic and operational oversight of PTC's Pharmacovigilance (PV) vendor.

Essential Functions

• Leads, oversees and actively contributes to the development, implementation and maintenance of a robust safety reporting system compliant with current applicable regulations. This includes closely managing the PV vendor and the case workflow, reviewing samples of cases to ensure ICSR quality and compliance with regulatory timeframes.
• Supports training the PV vendor on new products and compliance requirements.
• Supports PV set up and implementation of new studies/programs, including interventional Clinical Trials and Post authorisation safety studies.
• Reviews and contributes to PV vendor operational documentation, such as operational plans and program specific work instructions.
• Oversees safety database configuration, ensuring it meets applicable regulations and program needs.
• Ensures the quality, completeness and timeliness of delivery of all outputs from the safety database supporting routine safety oversight activities, aggregate reports, ad hoc Health Authority requests, etc.
• Supports PTC's PV strategic business continuity plan.
• Authors ICSR related processes and assists with the development, implementation and ongoing enhancement of related SOPs.
• Maintains and archives manual and electronic drug safety files pertaining to ICSR management.
• Performs other tasks and assignments as needed and specified by management, including line management.

Knowledge, Skills, Abilities, and Requirements

• Minimum level of education: BSN/RN, Bachelor's degree in Biological Sciences, Pharmacy or PharmD preferred with a minimum of 7 years progressively responsible pharmacovigilance experience, at least 3 of which in a leadership role.
• Strong knowledge of FDA, EU and ICH guidelines, initiatives, regulations governing pharmacovigilance.
• Hands on working knowledge of MedDRA terminology and the processing of AEs/SAEs.
• Hands on experience with Argus Safety database.
• Experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality (e.g., SAE reporting throughput rate).
• Ability to identify opportunities to improve the PV reporting process(es).
• Ability to influence without direct authority.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively in a fast paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including ability to support and prioritize multiple projects.

Preferred Knowledge, Skills, and Licenses

• Understanding of safety database administration, configuration, data entry and extraction.
• Expertise in Electronic Document Management System (eDMS) software.
• Expertise in WHODD with relevance to coding suspect drug and concomitant medications.

Travel Requirements

0 10%

Physical Requirements

Office / Remote based position.

EEO Statement

PTC Therapeutics is an equa