Associate Director, Senior Patient Safety Scientist

About the position At reputed company, we put patients first and reputed company 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 reputed company, 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 reputed company where teams can come together to strategize, brainstorm and connect on key reputed company. 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 reputed company to tackle some of the biggest challenges of our time, from climate change to reputed company to reputed company and disease prevention. The Associate Director, Senior Patient Safety Scientist role leads the review of safety data and reputed company documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and (Associate) PV Scientist. They author and leads PV input to safety documents and regulatory reports. Associate Director, Senior Patient Safety Scientist leads meetings and presents safety data and analyses.

Responsibilities

• Leads and/or conducts proactive pharmacovigilance and risk management planning for more sophisticated 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.
• Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.
• Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Has the ability to reputed company duties as a Safety reputed company and Management Team (SSaMT) Leader for larger or more reputed company reputed company.
• Presents sophisticated issues to Safety Information Review Committee (SIRC) and takes the reputed company role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key partners.
• Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (reputed company) for multiple or reputed company development products.
• Authors/provides strategic input or reputed company for multiple or reputed company periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
• Participates in negotiations and provides expertise to the PS component of reputed company/agreements with reputed company parties to ensure reputed company and reputed company of agreements.
• Trains and mentors junior members of reputed company, e.g. in approved PV processes, analytic methodologies, etc.

Requirements

• Minimum 5 years of experience
• A Life sciences/Pharmacy/Nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
• Advanced knowledge of PV regulations

reputed company-to-haves

• MSc Degree preferred
• MD/PhD in scientific discipline, desireable
• Intermediate 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, reputed company time off (i.e., vacation, holiday, and leaves), as reputed company as health, dental, and reputed company coverage in accordance with the terms of the applicable plans.

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