Senior Director, Safety Physician Global Pharmacovigilance

Rockville, MD, United States

Job Details: Senior Director, Safety Physician Global Pharmacovigilance Full details of the job.

Vacancy Name

Vacancy Name Senior Director, Safety Physician Global Pharmacovigilance

Vacancy No

Vacancy No VN258

Employment Type

Employment Type Full Time

Location of role

About the Company

About the Company Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners.

Key Responsibilities

Key Responsibilities 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 assists in the successful development, 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 postmarketing 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

• Provide clinical and strategic input to the design of clinical trials, signal refinement/validation activities post authorization studies, risk minimization and risk communication.

• Leadership of clinical safety sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory committees.

• Responsible for the development of review/response documents for safety issues arising from internal review or regulator feedback.

• Chair the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), trending, risk management planning, and making recommendations related to safety issues

• 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), 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)

• Maintain knowledge of Immunocore disease and therapeutic areas for marketed products and products in development

• 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.

• 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 participating in clinical development programs and providing leadership concerning the collection of information to define the safety profile of a product.

• Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit risk assessment, and risk management strategies.

• Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.

• Experience in Pharmacovigilance processes, particularly with individual case review and evaluation.

• Demonstrated ability to priorities multiple tasks and deliver to deadline with high standard of quality.

• Experience with commercially available safety databases.

Desirable

• Knowledge of drug approval process in major countries

• Knowledge of regulatory requirements concerning pharmacovigilance in different countries/regions

EDUCATION & QUALIFICATIONS

• M.D./D. O degree with at least four years of pharmacovigilance experience

• At least three years of practical clinical experience post licensure

Annual salary range:

This position is eligible for standard Company benefits, including medical, dental, vision, time off and 401k, as well as participating in Immunocore's annual incentive plans. Incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level.

US $284,866 - $310,082

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