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Safety Physician, Global Pharmacovigilance

Rockville, Maryland, United States

SAFETY PHYSICIAN, GLOBAL PHARMACOVIGILANCE 

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

This position can be located in Rockville, MD or Conshohocken, PA

The Role:

The Safety Physician, Global Pharmacovigilance, is 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 PV&RM. This position contributes to 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 PV&RM Medical Director assists in 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.

Responsibilities:

  • 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 postmarketing 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.
  • Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g. Company Core Safety Information (CCSI), Investigator Brochure (1B), national labels).
  • Actively participate in a multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues.
  • 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.

Experience & Knowledge:

Essential

  • Experience in PGV, particularly with individual case review and evaluation.
  • Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues.
  • Knowledge of clinical development process.
  • Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.
  • Demonstrated ability to prioritise 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 two years of pharmacovigilance experience and at least two years of clinical experience or relevant experience to understand clinical drug development.

Lead with Science and Discover What is Within:

  • We value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Medical benefits, beginning your first day of employment
  • Vision benefits
  • Fully paid Dental Insurance
  • 20 days’ vacation plus holidays
  • Fully paid Life Insurance and Disability
  • 401(k) with Company Match

Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position. 

Immunocore is an E-Verify employer.   

Applicants have rights under Federal Employment Laws:

Family and Medical Leave Act

Equal Employment Opportunity Commission

Employee Polygraph Protection Act

Uniformed Services Employment and Reemployment Rights Act (USERRA)

Right to work

EEO is the Law Supplement

Pay Transparency

 

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