Director, Safety Physician

American Society of Clinical Oncology (ASCO); United Kingdom; On-site; GBP 70,000 - 100,000; Full time

Job summary

A leading company in the pharmaceutical industry seeks a Safety Physician to oversee safety evaluations and risk management within Pharmacovigilance. This role emphasizes the importance of proactive risk assessments and collaboration with cross-functional teams to ensure safety compliance and management. Candidates should possess a medical degree along with extensive experience in pharmacovigilance.

Qualifications

• At least three years of pharmacovigilance experience required.
• Knowledge of clinical development processes is essential.
• Experience in authoring safety reports for regulatory submissions.

Responsibilities

• Conduct medical reviews of individual case safety reports (ICSRs).
• Develop safety evaluation strategies for clinical studies.
• Collaborate with various functions to ensure effective safety reporting.

Skills

Communication Proficiency

Collaboration Skills

Analytical Skills

Problem-Solving Skills

Time Management

Education

M.D./D.O degree

Tools

Safety databases

Job description

The Safety Physician, Global Pharmacovigilance, should be a physician with training and experience in Pharmacovigilance and Risk Management in the pharmaceutical/biotech industry to contribute to the overall medical oversight and safety evaluation within Pharmacovigilance and Risk Management. This position is responsible for the proactive and timely risk-benefit assessments of safety data to characterize the emerging and known safety profiles of development and marketed company products. The Safety Physician is responsible for the successful implementation, execution and maintenance of safety-related strategies, processes and systems that conform to the company's business strategy, industry standards and compliance with global regulations. This individual will provide guidance to third party vendors and to internal/external staff in the collection, evaluation and processing of adverse events from clinical trials and post-marketing surveillance. This role provides an excellent opportunity to collaborate closely with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.

KEY RESPONSIBILITIES:
• Develop strategies for assigned projects for safety evaluation and reporting that provide a consistent approach to emerging safety findings from ongoing clinical studies. Gain cross-functional input and agreement with strategies and oversee implementation. Amend strategies based on increased understanding of the safety findings from regular individual cases and aggregate reports.
• Provide leadership across functions to consistently approach safety reporting for data collection to ensure consistency between PV and Clinical Operations and Clinical Development working as an integrated team based on data and pharmacovigilance perspective to support future labelling.
• Conduct medical review of individual case safety reports (ICSRs) including identification of appropriate follow-up requests of important medical information for the proper medical assessment and evaluation of cases.
• Ensures ICSRs are medically accurate, complete, coded appropriately (MedDRA), with appropriate causality assessment, seriousness and expectedness.
• Ensures accuracy and timeliness of expedited reports and periodic reports from post-marketing surveillance and clinical trials.
• Participates in the identification, analysis and reporting of possible trends and concerns with company products including the identification and evaluation of safety signals through assessment of single case safety reports, aggregate trend analyses, and literature review.
• Responsible for the review and communication of safety data trending, signaling and other safety-related issues originating from any source for the purpose of detecting and reviewing safety signals in a timely manner via the Safety Governance process.
• Participate in the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues.
• Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labelling (e.g. Company Core Safety Information (CCSI), Investigator Brochure (1B), national labels), Risk Management Plans (RMP).
• Collaborate with key stakeholders including business partners in appropriate safety analyses and risk assessment and management strategies.
• Author medical-safety sections of aggregate safety reports (DSUR, PBRER).
• Participate in development of safety-related responses to queries from Regulatory Authorities.
• Participate in development of internal PV business infrastructure including standard operating procedures and work practice instructions to ensure seamless PV processes.
• Maintain knowledge of Immunocore disease and therapeutic areas for marketed products and products in development.
• Demonstrate knowledge and ensure compliance with applicable global PV regulations and guidelines (e.g. CIOMS, FDA, EMA, ICH, etc.).

COMPETENCIES:
• Communication Proficiency.
• Good clinical skills.
• Time Management.
• Collaboration Skills both internally and with outside parties.
• Personal Effectiveness/Credibility.
• Flexibility.
• Technical Capacity.
• Stress Management/Composure.
• Appropriate experience with Regulatory Agency and KOL interactions.
• Knowledge of pharmacovigilance relevant regulations, guidelines, and industry standards.
• Strong influencing skills with the ability to explain and defend a position in the face of opposition.
• Takes ownership of appropriate issues.
• Excellent analytical and problem-solving skills.
• Able to function in a remote office environment.

EXPERIENCE & KNOWLEDGE:
Essential
• Experience in Pharmacovigilance, particularly with individual case review and evaluation.
• Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit risk assessment, and risk management strategies.
• Knowledge of clinical development process.
• Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.
• Demonstrated ability to prioritize multiple tasks and deliver to deadline with high standard of quality.
• Experience with different commercially available safety databases.
Desirable
• Knowledge of drug approval process in major countries.

EDUCATION & QUALIFICATIONS:
• M.D./D.O degree with at least three years of pharmacovigilance experience, and at least two years of clinical experience or relevant experience to understand clinical drug development
• At least three years of practical clinical experience post licensure