Associate Director, Pharmacovigilance - Safety Scientist

The Associate Director, Pharmacovigilance (PV) performs the function of Safety Scientist within the PV department for both clinical trials and post-marketing surveillance support for PTC products.

He/she leads and project manages deliverables including, but not limited to, aggregate reports and risk management plans. He/she actively contributes as needed to signal detection activities and the safety review board.

The Associate Director, Pharmacovigilance (PV) works cross-functionally with internal departments/key stakeholders and external resources on PV-related matters to adhere to global PV regulations and requirements.

• Is responsible for assigned product(s) or therapeutic area PV activities.
• Functions as the overall project manager for compiling PV aggregate reports including, but not limited to, Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER), topic reports.
• Collaborates with safety physician to ensure effective planning such that stakeholder input is requested/received for applicable sections of PV reports to meet regulatory reporting deadlines.
• Contributes to relevant sections of PV safety reports in collaboration with the safety physician.
• Provides training and guidance to other functions to address ad hoc questions and issues pertaining to PV safety reports.
• Leads the review process for PV aggregate reports and oversees their finalization, working in conjunction with internal/external stakeholders.
• Collaborates with clinical teams, CROs, Regulatory Affairs and other stakeholders as needed to ensure aggregate reports are submitted to appropriate regulatory authorities within required timelines and tracks this information.
• Functions as the overall project manager for compiling safety information for Clinical Overviews, responses to regulatory questions, post-marketing safety assessment, Risk Management Plans, labeling justifications, Company Core Safety Information (CCSI) development, Investigator Brochures (IBs) update, label update(s) as well as written summaries
• Provides and ensures oversight for the technical and scientific support for safety surveillance and signal detection activities for PTC products.
• Alongside the safety physician, provides planning for, and ensures the conduct of, routine and ad-hoc cross-functional Safety Review Board (SRB) meetings.
• Contributes to the update of Risk Management Plans (RMPs) and ensures that regulatory and RMP commitments are efficiently tracked and presented as part of the SRB process. Liaises with SRB chair/s to facilitate communication and support for decisions resulting from the SRB. (e.g. update of RMPs, labeling, regulatory notifications or other actions as required).
• Collaborates with key stakeholders outside of PV. Represents PV department in cross-functional clinical program teams, providing support to development programs and registration activities.
• Provides support to Drug Safety Monitoring Board and clinical trial support. · Contributes to investigator meetings, as needed.
• Interfaces with medical monitors for medical assessment and regulatory classification of SAEs; facilitates SAE reconciliation across projects.
• Assists as needed with serious adverse event follow-up and case closure.
• Performs other tasks and assignments as needed and specified by management.
• Works closely and collaborates with EU and local Qualified Person (QP) to develop new or maintain PV processes supporting both development and marketed/commercial products.

• Experience in Gene Therapy is a strong advantage

*Special knowledge or skills and/or licenses or certificates preferred.

Expertise in the use of Electronic Document Management System (eDMS) software.

* Travel requirements

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