Easter Seals Jobs

Job title : Global Safety Lead

• Location: Hyderabad

At Sanofi Consumer Healthcare, our Science Hub mission is to empower our consumers to take Health in their Hands! With your talent and ambition, we can do even more to build our Sciences activities and develop breakthrough innovations for consumers worldwide. Your job, as Global Safety Lead within our Scientific Communications/Education Team.

At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. 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 people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.

Within the CHC – Consumer Safety organization, under the direction of the Global Pharmacovigilance Team Lead, the Global Safety Lead (GSL) will provide scientific and safety lead safety related activities including signal & risk management, benefit risk in alignment with Global Consumer Safety group.

The GSL 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 collaborating with relevant CSHs (Country Safety Heads) for any local impact on assigned global products/global INNs.

Main Responsibilities:

• As safety expert for products, GSL assures their ongoing safety profile assessment.

• Provide PV and risk management expertise to internal and external customers.

• Maintain knowledge of product, product environment, and recent literature.

• Maintain PV expertise and understanding of international safety regulations and guidelines.

• Communicate with and represent PV analyses and PV position within project/product management, in safety governance and benefit-risk governance activities and committees (e.g. Safety Management Committee, MRPTC), with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations.

• Responsible for signal detection and analysis. Identify and implement proactive safety analysis strategies to further define the safety profile. Lead aggregate safety data review activities and coordinate safety surveillance activities.

• Provide proactive risk assessment. Develop REMS, Risk Management and Development Risk Management plans, corresponding risk management strategies, safety action plans, their implementation and monitoring of effectiveness, as appropriate. Co-lead benefit-risk assessment with other relevant functions optimizing product benefit risk profile. Enable appropriate risk management. Enable up-to-date risk communication (e.g. labeling).

• Provide strategic and proactive safety support and input into clinical trials and development plans.

• Support due diligence activities on product safety for acquisition and divestment and Pharmacovigilance agreements.

• Review, prepare, contribute and/or approve clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labelling Review, prepare, and/or contribute to questions from health authorities, ethics committees, IRBs, external partners.

• Manage product safety alerts.

• For GSL appointed to lead RX (prescription) to OTC switch: lead the safety strategy of the switch, assess suitability of molecule for switch, prepare assessment reports to support the switch, attain knowledge on Actual Use Trials, Self Selection Studies, Labeling comprehension studies as well as behavioral studies.

• Represent safety position in cross functional submission teams ensuring generation, consistency, and quality of safety sections of relevant documents.

• For products under clinical development: Clinical Development Plan, study protocol, Statistical Analysis Plan, data monitoring plan, investigator brochure, Informed Consent Form, study report, Integrated Summary of Safety, Summary of Clinical Safety, risk management plan, label, periodic reports.

• For marketed products: Response to health authority question/request for information, Core Safety Information updates, periodic reports.

• Document, contribute to, coordinate, review and/or validate Periodic Reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report.

• Write responses or contributions to health authorities’ questions. Support preparation and conduct of Advisory Committee meetings.

• Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products.

• Collaborate with Global Science CoE Head to support on any additional activities.

About you

• Experience:

Minimum of 5 years of experience in pharmacovigilance or drug safety in the role of a Global Safety Officer/Lead.

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

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

Experience in medical writing, safety reporting, Health Hazard Evaluations, Signal Management, Risk Management and Benefit Risk.

• Soft skills: Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment .

• Technical skills: Strong knowledge of GxP and PV systems and strong knowledge of Signal and Risk Management, Benefit Risk and overall Medical Safety activities.

• Education: Medical Degree (MBBS or MD) in allopathic/conventional medicine.

• Languages: Excellent knowledge of the English language (to read, write, and speak)

Pursue progress , discover extraordinary

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, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)