Pharmacovigilance Physician Job at Venesco LLC, Frederick, MD

QkIwdmltUnAvbDM0YXR2aS8yL2V0QXVIS1E9PQ==
  • Venesco LLC
  • Frederick, MD

Job Description

Job Type

Full-time

Description

Pharmacovigilance Physician

Venesco is seeking a Pharmacovigilance Physician to provide medical oversight and clinical expertise for all safety surveillance and pharmacovigilance activities. The physician is responsible for medical review of adverse events, causality assessments, safety signal evaluation, benefit-risk analyses, and regulatory safety reporting.

Requirements

Duties and Responsibilities

  • Review and assess serious adverse events.
  • Perform causality and expectedness assessments.
  • Lead benefit-risk evaluations and signal detection activities.
  • Support expedited regulatory reporting requirements.
  • Participate in DSMBs and safety review committees.
  • Review protocols, Investigator Brochures, and informed consent forms.
  • Contribute to IND safety reports, annual reports, DSURs, and safety communications.
  • Provide medical safety consultation to project teams.
  • Support safety surveillance and risk management planning.
  • Participate in regulatory inspections and audits.

Minimum Qualifications

  • Doctor of Medicine (MD) degree.
  • Current unrestricted U.S. medical license.
  • Board Certified Physician.
  • Minimum 10 years of clinical or pharmaceutical industry experience.
  • Extensive drug safety and pharmacovigilance experience.
  • Strong knowledge of FDA and ICH pharmacovigilance requirements.

Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.

For more information on Venesco, LLC., visit .

Job Tags

Full time

Similar Jobs

INNOVATIVE THE COLLIER AT NAPLES

ACTIVITIES DIRECTOR Job at INNOVATIVE THE COLLIER AT NAPLES

 ...Activities Director We are seeking a dynamic and creative Activities Director to join our team. The ideal candidate will be responsible for planning, organizing, and overseeing a wide range of recreational and leisure activities tailored to meet the interests and needs... 

ATC Portland

Phlebotomist Job at ATC Portland

 ...Phlebotomy Certification (where applicable)* Current Basic Life Support (BLS) Certification through the American Heart Association (AHA) or the American Red Cross* Minimum of 1-2 years of recent phlebotomy experience* Proficient in venipuncture and specimen... 

Red Bull

Sr. Manager, Partnership Sales Job at Red Bull

 ...RedBull New York (RBNY) is one of 30 clubs competing in Major League Soccer (MLS) and has been part of the league since its inaugural season in 1996. As one of MLS's original charter clubs, RBNY has built a strong legacy both on and off the field. The First Team plays... 

Confidential

Travel Radiology Diagnostic Imaging Manager Job Job at Confidential

 ...Job Description Are you an experienced Diagnostic Imaging Manager seeking an exciting travel healthcare assignment in the picturesque...  ...-week assignment, you will oversee the daily operations of the radiology department, ensuring efficient delivery of diagnostic imaging... 

InGenesis

Temporary Administrative Security Specialist - (13309) Job at InGenesis

 ...We are currently seeking a Temporary Administrative Security Specialist to join our team. In this role, you will support the administrative functions required to gain and maintain security clearances and approval to work on government contracts. This person will work...