Director/Sr. Director of PV Sciences

The primary responsibilities of the Director/Sr. Director of PV Sciences at Scholar Rock include leading patient safety and risk management activities such as signal detection and management, preparing aggregate safety reports, and overseeing the Pharmacovigilance Scientist group. You will be responsible for the safety governance of our drug products, developing risk management strategies, and engaging in cross-functional teams to uphold the highest patient safety standards.

To apply for the Director/Sr. Director of PV Sciences position at Scholar Rock, candidates should hold an MSc or PhD in a health science field such as nursing or pharmacy, along with at least 7 years of relevant drug safety and risk management experience in the pharmaceutical, biotech, or CRO industry. A strong working knowledge of pharmacovigilance regulations and previous involvement in drug safety governance are also critical.

At Scholar Rock, the Director/Sr. Director of PV Sciences plays a crucial role in managing patient safety through rigorous evaluation and benefit-risk assessments across the product lifecycle. This includes preparation and review of important safety-related documents and active participation in safety governance meetings to ensure compliance with regulatory standards. The position also involves continuous oversight of pharmacovigilance strategies to quickly respond to any safety signals that arise.

The work performed by the Director/Sr. Director of PV Sciences at Scholar Rock is significant in that it directly impacts the safety and efficacy of our innovative therapies. By leading patient safety efforts, managing risk assessments, and ensuring adherence to global regulations, the role is vital to not only protecting patients but also advancing the development of groundbreaking treatment options in biopharmaceuticals.

The Director/Sr. Director of PV Sciences will manage a dedicated team of Pharmacovigilance Scientists. This team plays an essential role in monitoring and evaluating drug safety throughout the development process. Under this leadership, team members will engage in risk management activities, contribute to safety governance, and support all safety-related aspects within the organization, further enhancing Scholar Rock's commitment to patient safety and therapeutic innovation.

Pharmacovigilance refers to the scientific discipline focused on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It is crucial for ensuring patient safety and maintaining the benefit-risk balance of pharmaceutical products.

When discussing my experience with risk management plans, I emphasize the importance of developing comprehensive strategies that monitor potential risks associated with a drug throughout its lifecycle. I have a solid track record in drafting and maintaining these plans, ensuring they align with both regulatory guidelines and company standards.

I believe in employing various signal detection methodologies, including statistical analysis of adverse event reports and literature review to monitor trends over time. Additionally, I emphasize cross-functional collaboration to validate findings and implement timely risk management strategies.

In my previous role, I led the authoring of safety-related sections for regulatory submissions like IND and NDA/BLA. I collaborated closely with clinical teams to gather necessary data and ensure all documents accurately reflect the drug’s safety profile, facilitating successful approvals.

I stay up-to-date by regularly attending industry conferences, participating in webinars, and reviewing regulatory authority updates. I also subscribe to professional journals that focus on pharmacovigilance and drug safety to keep abreast of changes and trends affecting the field.

Statistical analysis is key in pharmacovigilance as it helps identify safety signals and establish correlations between drugs and adverse events. I utilize various analytical tools and software to assess data effectively, allowing for data-driven decision-making in risk management.

Leading safety governance meetings involves coordinating discussions among cross-functional teams regarding emerging safety issues. I prepare agendas, facilitate discussions, and ensure that action items are documented and followed up on to maintain our commitment to patient safety.

A common challenge in pharmacovigilance is managing discrepancies in adverse event reports. I address this by implementing standardized reporting procedures and enhancing training for the teams involved, ensuring everyone is aligned in data collection and transparency.

I prioritize open and transparent communication with regulatory agencies. I engage with them during safety queries and ensure timely response to their concerns. I also participate in inspections as a subject matter expert to establish and maintain trust.

Effective communication is crucial as it ensures that all stakeholders—internally within the organization and externally with regulatory bodies—are aligned and informed regarding product safety and risk management activities. It helps foster collaboration and enhances our ability to respond promptly to emerging safety concerns.