Senior Pharmacovigilance Officer

5+ years

Not Disclosed

Remote, USA

10 Dec. 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Pharmacovigilance Officer
Location: Reading, UK

About the Job:
As a Senior Pharmacovigilance Officer at Sanofi, you will play a critical role in evaluating safety data for assigned products, contributing to the development of risk management plans, and collaborating on signal detection with the Global Safety Operations (GSO) team. This is an exciting opportunity to be part of a global healthcare leader focused on delivering groundbreaking innovations that improve the lives of patients worldwide. You’ll have the chance to develop professionally while making a meaningful impact on drug safety and pharmacovigilance processes.

Main Responsibilities:

Monitor and document safety data to identify trends, potential signals, and issues.
Handle risk management, signal detection, and periodic reporting across a broad scope of responsibilities.
Contribute to the preparation of Pharmacovigilance-related documents, such as PSURs, RMPs, safety assessments, and additional risk minimization materials for internal and external use.
Ensure a timely response to requests for further information from the Sanofi Global PSPV team or MHRA.
Maintain and update Pharmacovigilance procedures in line with current regulations and company policies.
Conduct compliance and quality checks, overseeing partner and outsourced service provider compliance.
Collaborate with the management team to ensure PV procedures remain aligned with national, European, and international regulations and guidelines.
Participate in audits and inspections, contributing to the development of corrective and preventive actions when necessary.

About You:

A degree in Life Sciences or qualification as a health professional.
Practical experience in Drug Safety/Pharmacovigilance, including knowledge of risk management, signal detection, PSURs, and safety assessments.
Strong attention to detail, excellent analytical abilities, and organizational skills.
Good oral presentation skills and scientific writing capabilities.

Why Choose Us?

Be part of a supportive, future-focused team that brings the miracles of science to life.
Explore endless opportunities for career growth, whether through promotions or lateral moves, both locally and internationally.
Receive a thoughtful and competitive rewards package that recognizes your contribution.
Enjoy a wide range of health and wellbeing benefits, including high-quality healthcare, wellness programs, and gender-neutral parental leave (at least 14 weeks).

Pursue Progress, Discover Extraordinary.
Join Sanofi in our pursuit of progress, where diverse people from various backgrounds and locations work together to create extraordinary outcomes. Let’s embrace change, explore new ideas, and make miracles happen. Together, we’ll continue to make a positive impact on the world.

Additional Information:
Visas for those who do not already have the right to work in the UK will be considered on a case-by-case basis according to business needs and resources.

At Sanofi, we believe in equal opportunities for all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Explore our Diversity, Equity, and Inclusion actions at sanofi.com.

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Senior Pharmacovigilance Officer

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