Director, Global Patient Safety Science

remote zest jobs; India; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

Remote zest jobs is seeking a Director, Global Patient Safety Science to lead safety science and pharmacovigilance activities across the RevMed portfolio. The role involves providing safety input into study management, and maintaining expert understanding of product safety throughout the lifecycle.

Responsibilities include safety surveillance, risk management, regulatory submissions, and mentoring Safety Scientists within a flexible matrix team to ensure robust safety analyses and risk

Qualifications

• 8 or more years of drug development experience in pharmaceutical industry with Safety Science background.
• Excellent ability to evaluate, interpret and present scientific data.

Responsibilities

• Responsible for safety surveillance and risk management activities including medical review of IC SRs and routine review of safety data.
• Contribute to the review of assessments for safety signals or regulatory authority responses.
• Providing medical safety input into the design and conduct of pharmacoepidemiology and observational studies.
• Plan and interpret safety data analyses, prepare and present safety data summaries to stakeholders.
• Develop and contribute knowledge of relevant drug class and safety issues.
• Establish and maintain collaborative working relationships with key stakeholders.
• Accountable for risk management activities including preparation and maintenance of regulatory documents.

Skills

Safety science

Pharmacovigilance

Data interpretation

Leadership

Education

Postgraduate qualification (MD, PharmD, PhD/MSc)

Job description

About the position

The Director, Global Patient Safety Science provides safety science and pharmacovigilance support to reputed company products across the RevMed portfolio, which includes early and late phase development activities as a member of the Global Patient Safety team. The individual will be responsible for safety reputed company and input into reputed company aspects of study management across the portfolio. This position may have individual reporting to it depending on the program/portfolio being led. The Director of Safety Science serves as the reputed company for multiple or large reputed company strategically important developmental programs. Also, works closely with the other functions as part of a flexible matrix team to conduct robust safety assessments and safety risk management activities. The Director, Global Patient Safety Science will reputed company and maintain an expert understanding of the safety profile of the assigned product(s) as well as an understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action, etc.) and is accountable for reputed company of benefit/risk safety profile of allocated products through the product lifecycle.

Responsibilities

• Responsible for safety surveillance and risk management activities including, but not limited to medical review of IC SRs, routine review of safety data, and pertinent scientific literature articles.
• Contribute to the review of assessments for safety signals or in response to Regulatory Authority requests.
• Providing medical safety input into the design and conduct of pharmacoepidemiology and observational studies.
• Plan and interpret safety data analyses, prepare and present safety data summaries to reputed company stakeholders.
• reputed company and contribute knowledge of relevant drug class and/or competitor safety issues.
• reputed company the development of safety surveillance strategy, identify potential clinical safety issues, and recommend appropriate risk mitigation measures.
• Establish and maintain collaborative working relationships with reputed company key stakeholders (e.g., clinical study teams, safety CROs, business partners).
• Accountable for risk management activities including preparation and maintenance of relevant sections of clinical trial protocols, IBs, ICFs, DSURs, RMPs, CCDS, and labelling.
• Contribute to regulatory authority submissions (Investigational New Drug applications, New Drug Applications, Marketing Authorization Applications, etc.).
• Developing response strategies in collaboration with safety committee members, providing medical-scientific input to regulatory documents for safety-reputed company requests from health authorities and other external parties.
• Evaluates risk minimization strategies and takes accountability for the medical-scientific content in the Risk Management Plans.
• Accountable for the safety components of study reports (i.e., CSRs), aggregate reports (DSUR, PSUR/PBRER, PADER) and other regulatory documents.
• Participate in reputed company Data Monitoring Committees through review of safety data, insights and leadership and development of DMC Charters.
• Reviews publications, including abstracts, manuscripts, and speaker presentations.
• Trains and mentors Safety Scientists.
• Consistently reputed company with reputed company governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.

Requirements

• 8 or more years of drug development experience in the pharmaceutical or reputed company industry, of which at least 4 years include prior Safety Science experience.
• A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life sciences discipline, or other post‑graduate health reputed company qualifications).
• Mentor, and reputed company a high‑performing Safety Science team.
• Excellent ability to evaluate, interpret and present scientific data with reputed company.
• Proven reputed company in creating and sustaining strong relationships with reputed company business partners.
• Experience with interacting with Regulatory Authorities (i.e. FDA, EMA) at type C, B, reputed company‑BLA/MAA meetings.
• Strong analytical and strategic thinking, problem‑solving, and decision‑making skills.
• Excellent communication, collaboration, and team management abilities.
• Extensive understanding of pharmacovigilance and risk management.
• Strong clinical leadership and experience.
• Outstanding emotional intelligence.

Preferred Qualifications

• Demonstrated ability to reputed company and influence in a global matrix environment.
• 2+ years of experience in Oncology clinical development.
• Proficiency in managing regulatory interactions, BLA/MAA experience.
• Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively.
• Excellent influence and collaboration/teamwork capabilities.
• Strong interpersonal and commun