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Associate Manager, Pharmacovigilance & Epidemiology

Expired Job

Gilead Sciences, Inc. Foster City , CA 94404

Posted 4 months ago

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Specific Responsibilities:

  • Signal detection and authorship of signal work-up documents in collaboration with Medical Evaluation

(ME) team member.

  • Authorship of CCDS sections and associated supporting documentation.

  • Authorship of aggregate safety reports (e.g., PSURs).

  • Authorship of risk management plans.

  • Authorship of responses to regulatory agency safety enquiries.

  • Contributes to safety analyses in Regulatory submissions (e.g., MAAs, NDAs).

  • Reviews global literature for identification of potential safety concerns.

  • Performs safety review of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies.

  • Reviews standard reference documents in collaboration with a ME team member

Essential Duties and Job Functions:

  • Work is performed under close supervision following established procedures.

  • Develops basic knowledge of pharmacovigilance, regulations, aggregate safety reports, risk management plans, signal detection, clinical trials, and clinical development.

  • Demonstrates ability to present results and findings and discuss processes in formal settings, including

Clinical Development Team, Study Management Team, and Product Safety Committee meetings.

  • Shows ability to effectively collaborate with cross-functional staff.

  • Communicates effectively to ensure relevant parties are fully informed and knowledgeable of project activities and their status.

  • Begins to establish recognition within the job family as a technical expert.

  • Familiar with searching drug safety and literature databases for relevant information.

  • Contributes to safety committee meetings (internal or with partner companies).

  • Participates as a member of various cross-functional teams, including participation on Clinical Development Teams involving interaction with Medical Monitors, Clinical Scientists, Clinical Operations, and other Medical Affairs personnel.

  • May act as a mentor to employees with less experience.

  • May lead projects with supervision.

Knowledge, Experience, and

Skills:
  • Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline (e.g. biology, chemistry, or neuroscience).

  • Some experience (2+ years) in the pharmaceutical industry, at a regulatory agency, or in clinical research is preferred

  • Demonstrates a good level of competency in verbal and written communication, including Microsoft Excel, Office, Word, and PowerPoint.

  • Demonstrates good analytical thinking skills, attention to detail, teamwork, initiative, and basic project management skills; maintains confidentiality; maintains meticulous attention to project deadlines.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For jobs in France:

Conformment la Loi " Informatique et Liberts " (06/01/78), nous vous informons du fait que les donnes personnelles renseignes pourront faire l'objet d'un traitement informatique par Gilead et pourront tre transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accs, de rectification et de suppression des donnes vous concernant. Vous pouvez exercer ce droit en contactant: FranceDataPrivacy@gilead.com

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.


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Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. Gilead Sciences, Inc. Foster City CA

Associate Manager, Pharmacovigilance & Epidemiology

Expired Job

Gilead Sciences, Inc.