Global Pharmacovigilance Group Lead

3-10 years

Not Disclosed

Hyderabad

10 Aug. 13, 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: Global Pharmacovigilance Group Lead

Location: Hyderabad

About Sanofi Consumer Healthcare:

At Sanofi Consumer Healthcare, we are dedicated to empowering individuals to take control of their health by developing trusted and loved brands that connect with millions of consumers worldwide. Our mission, "Health in Your Hands," drives us to challenge ourselves and the industry to build a healthier future. By integrating sustainability into our business and operations, we aim to positively impact the world while supporting our employees in a thriving, growth-oriented work environment. Together, we are committed to becoming the "Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World."

Our Team:

The Global Regulatory Strategy & Science Partner Markets Team is a diverse and inclusive group dedicated to achieving operational excellence in regulatory processes, supporting global decision-making, and bridging regulatory activities with brand needs. We strive to create value through a world-class Center of Excellence (CoE) structure, fostering continuous improvement and maintaining high performance standards.

Main Responsibilities:

As the Global Pharmacovigilance Group Lead (GPGL) within the CHC – Consumer Safety organization, you will report to the Global Science CoE Lead and provide scientific leadership for safety-related activities. This includes managing signal and risk management, benefit-risk assessments, non-clinical expertise (toxicology), and global safety for Sanofi's consumer care products. You will collaborate closely with the Medical Safety Head, Global Signal & Risk Management Lead (SRML), and Benefit Risk & Epidemiology Lead (BREL) to ensure safety compliance and regulatory alignment across the portfolio.

Key responsibilities include:

Leadership & Oversight: Direct and lead the Global Medical Safety team at the Hyderabad hub, overseeing safety assessments related to signal management, risk management, benefit-risk evaluations, and non-clinical expertise.
Strategic Collaboration: Partner with Global Medical Safety, Regional PV Heads, and functional leads to ensure proper alignment on safety matters and compliance with global, local, and regional PV regulations.
Regulatory Compliance: Ensure adherence to global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines. Prepare for and participate in regulatory inspections and audits, addressing findings and implementing corrective actions.
Team Development: Provide mentorship and leadership to team members, conducting regular performance reviews, offering feedback, and supporting professional growth. Promote a culture of continuous learning within the PV team.
Process Improvement: Develop and implement new processes and procedures in collaboration with the Global Science CoE Head. Stay current with advancements in pharmacovigilance and integrate new technologies and methodologies.
Training & Education: Develop and deliver training programs for local PV staff and other departments, ensuring compliance with PV processes and regulatory requirements.

About You:

Experience:

Minimum 10 years of experience in pharmacovigilance or drug safety, preferably within the consumer healthcare or pharmaceutical industry.
At least 3 years in a leadership or managerial role within pharmacovigilance.
Strong knowledge of global PV regulations (e.g., FDA, EMA, ICH) with a proven track record of leading and mentoring a team of PV professionals.
Experience in performance management, conducting reviews, and supporting team development.

Skills:

Soft Skills: Strong stakeholder and project management, strategic thinking, and communication skills. Ability to work independently and collaboratively in a cross-functional team environment.
Technical Skills: In-depth knowledge of signal and risk management, benefit-risk assessment, toxicology, and overall medical safety activities. Familiarity with regulatory requirements and continuous improvement management.

Education:

A Master's degree in life sciences, pharmacy, or a related field is typically required. Relevant fields include, but are not limited to, Pharmacy and Allopathic Medicine.

Languages:

Excellent command of the English language, both spoken and written.

Why Join Us?

At Sanofi, we believe that progress is driven by people—people from diverse backgrounds working together to achieve extraordinary outcomes. We are committed to providing equal opportunities to all and fostering an inclusive environment where every individual can thrive.

Pursue Progress. Discover Extraordinary.

Watch our ALL IN video and learn more about our Diversity, Equity, and Inclusion initiatives at sanofi.com.

Sanofi is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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Global Pharmacovigilance Group Lead

Job Description

Job Title: Global Pharmacovigilance Group Lead

About Sanofi Consumer Healthcare:

Our Team:

Main Responsibilities:

About You:

Why Join Us?

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