Global Safety Operational Group Lead

8-10 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 Safety Senior Manager (GSSM)

Job Location: Hyderabad

Our Team:

At Sanofi Consumer Healthcare, we are driven by one overarching mission: to passionately challenge ourselves and the industry to build a healthier future by empowering people to take charge of their health. Our commitment to bringing "Health in Your Hands" is reflected in our dedication to building trusted and beloved brands that connect with millions of consumers worldwide. Through better self-care, we aim to improve individual and community health while contributing to a healthier planet. We believe that to become the "Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World," we must engage our consumers, customers, healthcare professionals, and employees in this journey. By integrating sustainability into our business and our employees' mission, we strive to operate responsibly from both a social and environmental perspective.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we are committed to creating a work environment where people can thrive, grow, and perform at their best every day. Our priority is working with integrity to improve the health and well-being of the people and communities we serve, making a positive impact on the world.

Your Role:

As the Global Safety Senior Manager (GSSM) within the CHC – Consumer Safety organization, you will operate under the direction of the Global Science Centre of Excellence (CoE) Lead. In this key role, you will provide operational leadership to a team responsible for managing safety reporting in clinical studies, literature management, periodic reports, PV agreements, case management, and PV systems and data analytics. Your efforts will be closely aligned with the Global Consumer Safety group PV Operations team.

Key Responsibilities:

Team Leadership: Directly oversee and lead the Global Safety Operations team at the Hyderabad hub, managing activities related to case management, literature surveillance, periodic reporting, partner management, and data analytics.
Collaboration: Work closely with the PV Operations Head, Global Case Management Lead, and PV Systems Head to support activities for assigned consumer care products. Ensure alignment with the PV Operations team’s goals and objectives.
Operational Management: Plan, schedule, and manage daily work activities within the team to meet or exceed established key performance indicators (KPIs).
Performance Reviews: Conduct regular performance reviews, provide feedback, and support the professional development of team members, ensuring alignment with the global PV Operations team.
Regulatory Compliance: Ensure compliance with global PV regulations, including FDA, EMA, and ICH guidelines. Lead efforts during regulatory inspections and audits, addressing audit findings, and implementing corrective and preventive actions (CAPAs).
PV Agreements: Provide leadership in managing PV agreements, ensuring adherence to global standards.
Continuous Improvement: Stay current with advancements in pharmacovigilance and drug safety, integrating new technologies and methodologies into daily operations.
Additional Support: Collaborate with the Global Science CoE Head to support additional activities as needed.

About You:

Experience:
- 8-10 years of experience in pharmacovigilance operations.
- Preferred experience in consumer healthcare, pharmaceuticals, or related industries.
- At least 4 years of experience in a leadership or managerial role within pharmacovigilance.
Skills:
- Leadership: Proven ability to lead and mentor a team of PV professionals, managing performance, and supporting professional development.
- Technical: Strong knowledge of global PV regulations, Signal and Risk Management, Benefit-Risk analysis, toxicology, and Medical Safety activities. Familiarity with EMA/FDA/ICH regulations.
- Soft Skills: Stakeholder management, project management, strong analytical and problem-solving skills, strategic thinking, and effective communication. Ability to work both independently and in a collaborative, cross-functional team environment.
Education:
- A scientific degree (e.g., BS, MS, Pharmacy) or an equivalent combination of relevant education and professional experience.
Languages:
- Excellent command of the English language, both spoken and written.

Join Us:

At Sanofi, we believe that progress doesn’t happen without people—people from diverse backgrounds, in different locations, united by a common desire to make a difference. We are committed to providing equal opportunities to all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Together, let's pursue progress and discover the extraordinary.