Apply

Senior Pharmacovigilance Scientist

Rockville, Maryland, United States

SENIOR PHARMACOVIGILANCE SCIENTIST, 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.

The Role:

The  Senior Pharmacovigilance Scientist supports the operational and medical components of pharmacovigilance activities including surveillance activities providing scientific/clinical pharmacovigilance expertise with focus on the identification, evaluation and management of safety risk for Immunocore products.  The role will collaborate closely with the safety physician and cross-functional partners to evaluation and actively manage risks in accordance with global regulatory frameworks.

Responsibilities:

  • Perform routine and ad hoc safety surveillance activities such as signal detection, literature search and risk management to support the safety physician on one or more programs.
  • Take lead in managing and reviewing periodic safety reports (e.g. DSUR, PSUR, PBRER)
  • Provide support to PV operations in ICSR quality oversight and in working with QA to maintaining a state of high PV inspection readiness across all regions/countries.
  • Contribute to activities in the monitoring of compliance with regulations and development of internal SOPs related to PV function.
  • Represents PV department on clinical development teams, as assigned.
  • Perform medical review of some individual case safety reports.
  • Participate in regulatory inspections/audits and related activities; prepares responses to audit findings that concern the PV department.
  • Supports the safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts.
  • Keeping current on relevant regulations associated with the above activities.
  • Support company REMS and RMP activities.

Qualifications: 

Essential

  • Minimum 2 years relevant medical, scientific/clinical, or pharmaceutical experience, including experience in drug safety servient in PV Scientist or similar role.
  • Degree in Biomedical or Health Care related specialty (MD, RN, MS, RPh, MPH).
  • Strong knowledge of clinical development process.
  • Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality.
  • Expert evaluation skills and analytical thinking.
  • Demonstrated ability to work effectively either independently or collaboratively in a team environment, both internally or with external colleagues.

Desirable

  • Knowledge of drug approval process in major countries.

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.  

 

YOUR DETAILS

Field required
Field too short, min characters: 2
Field required
Field too short, min characters: 2
Invalid email address
Field required
Field too short, min characters: 2
Invalid phone number
Field required
Field too short, min characters: 2
Field required
Field too short, min characters: 2

SECONDARY INFORMATION

Field required
Field too short, min characters: 2
Field required
Field too short, min characters: 2
Field required
Field too short, min characters: 2
Field required
Field too short, min characters: 2

COMPLIANCE - 1

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in this company’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Field required
Field too short, min characters: 2
Field required
Field too short, min characters: 2

COMPLIANCE - 2

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Field required
Field too short, min characters: 2

COMPLIANCE - 3

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression
Field required
Field too short, min characters: 2

Uploads

Upload your Resume/CV (PDF max: 4Mb)

Upload your Cover Letter (Optional) (PDF max: 4Mb)