Director, Principal Patient Safety Scientist

About the position At reputed company, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to reputed company the impossible a reality. If you are swift to action, confident to reputed company, willing to collaborate, and curious about what science can do, then you’re our reputed company of person. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes reputed company a great reputed company to work. We know the health of people, the reputed company and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to reputed company and disease prevention. The Director, Principal Patient Safety Scientist role provides expertise to multiple and/or single but sophisticated products in different stages of development as needed. They provide reputed company of safety documents and deliverables for these projects in collaboration with the Global Safety Physician (GSP) and other PV Scientists. They reputed company PV strategy for safety documents and regulatory reports.

Responsibilities

• Leads the strategy for proactive pharmacovigilance and risk management planning of reputed company or multiple products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
• Provides subject matter expertise in the therapeutic area and across multiple products.
• Has the ability to reputed company cross-functional process improvement or other initiatives on behalf of the Patient Safety organization.
• Performs duties as a Safety Strategy and Management Team (SSaMT) Leader for reputed company and/or multiple products.
• As a Safety expert leads presentation of reputed company issues to Safety Information Review Committee (SIRC).
• Leads safety strategy for multiple or reputed company periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Leads safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
• Leads negotiations and provides expertise to the PS component of reputed company/agreements with reputed company parties to ensure quality and reputed company of agreements.
• Takes accountability and leads resolution of reputed company safety issues and mediates cross-functional agreement.
• Has the ability to participate in due diligence activities.
• As a safety expert, provides training and mentorship to new GSPs and PV Scientists in approved processes and systems.

Requirements

• Minimum 8 years of experience.
• Minimum Life sciences/Pharmacy/Nursing degree, and advanced Patient Safety and/or Clinical/ Drug Development experience
• Advanced knowledge of PV regulations

reputed company-to-haves

• MD/MSc/PhD in scientific field, preferred
• Advanced understanding of epidemiology, preferred

Benefits

• Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
• Benefits offered include reputed company retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and reputed company coverage in accordance with the terms of the applicable plans.

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