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Global Pharmacovigilance Group Lead

Hyderabad, India Permanent Date posted 11/07/2024
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Job Title: Global Pharmacovigilance Group Lead

Job Location: Hyderabad

Our Team:

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”. Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. 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 aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world. Our Team: The Global Regulatory Strategy & Science Partner Markets Team is a diverse and inclusive team striving to Build a culture of excellence by: Driving operational effectiveness for regulatory processes Enabling strategic decision making on global regulatory strategy portfolio Bridging regulatory portfolio activities with brand needs Monitoring regulatory performance and budget Ensuring operational excellence and ensuring continuous improvement in Partner Markets (G2) for Science Creating value through a best in classe CoE structure, processes and talented resources The CHC Science Center of Excellence (CoE) is an internal resource organization based in India and is set-up to centralize processes and activities to run and support Science Customer functions. The CoE strives to be a partner for strategic and tactical deliveries for CHC Science globally to sustain world-class performance and value.

Main responsibilities:

Within the CHC – Consumer Safety organization, under the direction of the Global Science CoE Lead, the Global Pharmacovigilance Group Lead (GPGL) will provide scientific leadership to the chosen team managing safety related activities including signal & risk management, benefit risk, non-clinical expertise (toxicology related) and global safety in alignment with Global Consumer Safety group.

The GPGL is responsible for collaborating with Medical Safety Head, Global SRML (signal & risk management lead) and Benefit Risk & Epidemiology Lead (BREL) to conduct safety activities for assigned consumer care products in company’s portfolio.

The role is also responsible for leading Pharmacovigilance (PV) related matters oversight of Group 2 Countries (distributor markets) and collaborate with Regional PV Heads and other functional leads for these markets to ensure proper PV alliance with distributors and cooperation within the organization. This will also include ensuring compliance with global, local and regional PV regulations to be implemented in these markets and to support during partner and health authority audits and inspections.

Directly oversee and lead Global Medical Safety team located at India (Hyderabad) hub location to conduct appropriate safety assessments related to signal management, risk management, benefit risk and non-clinical expertise.

Collaborate with Global Medical Safety team for coordination of above mentioned activities.

Work closely with resources working on same topics at vendor location to ensure proper alignment of safety matters.

Provide leadership and mentorship to the team members.

Conduct regular performance reviews, provide feedback, and support professional development of team members.

Oversee multiple activities within safety science group at local hub location.

Strategic lead for Group 2 countries to define partner responsibilities along with support during audits and inspections for these markets

Ensure compliance with global PV regulations, including FDA, EMA, and ICH guidelines.

Prepare for and participate in regulatory inspections and audits.

Address audit findings and implement corrective and preventive actions (CAPAs).

Stay current with advancements in pharmacovigilance and drug safety, and integrate new technologies and methodologies.

Collaborate with team members and approval from senior management to develop and implement any new processes/procedures. Collaborate with Global Science CoE Head to support on any additional activities.

Responsible for leading team overseeing safety-related activities for company products as per Global Consumer Safety policies.

Develop and deliver training programs for local PV staff and other departments on PV processes and regulatory requirements.

Promote a culture of continuous learning and professional development within the PV team.

About you

  • Experience: Minimum of 10 years of experience in pharmacovigilance or drug safety.

              Experience in consumer healthcare, pharmaceuticals, or related industries is preferred.

              At least 3years of experience in a leadership or managerial role within pharmacovigilance.

              Strong knowledge of global PV regulations and guidelines (e.g., FDA, EMA, ICH).

              Proven track record of leading and mentoring a team of PV professionals.

Experience in performance management, conducting performance reviews, and supporting professional development of team members.

  • Soft skills: Stakeholder management; project management, communication skills; strategic thinking and ability to work independently and within a team environment

              Strong analytical and problem-solving skills.

              Ability to work collaboratively in a cross-functional team environment.

  • Technical skills:

       Strong knowledge of Signal and Risk Management, Benefit Risk, toxicology, and overall Medical Safety activities,  Regulatory and company requirements, specifically pharmaceutical drug Regulations, e.g. EMA/FDA/ICH Regulations, Basic 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 , Medicine (Allopathic Medicine only – no alternative medicine)

  • Languages: Excellent knowledge of English language (spoken and written)

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.  

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.  

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com

Pursue Progress. Discover Extraordinary.

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