Country Safety Head India

Our Team:

The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable Sanofi to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers.

The PV Regions group is an international, dynamic, and culturally diverse team dedicated to the safety of Sanofi products in regions/countries.

The [Multi] Country Safety Head ensures that local PV activities are performed in compliance with the global/regional/local PV regulations and PSPV Quality Documents (QDs) to warrant safe and appropriate use of Sanofi products in the assigned country (or countries for the M-CSH).

CSH Main responsibilities:

• The face of the Safety organization in the country

• Accountable for all PV related activities in the country & ensures that the local PV teams are properly trained to manage these activities.

• Ensures inspection readiness of the PV system in the country, serves as the local PV contact for the local authorities and acts as the local Responsible Person for Pharmacovigilance (RPP) where applicable per country legislation (this role can be delegated as needed)

• Builds & maintains all necessary relations/collaboration with the key PSPV stakeholders as well as other CSHs, and with the in-country partner functions (including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Leads).

• Accountable for local PV outsourced activities and PV compliance of local partnerships

• Accountable for local PV resources and budget with both local & global supporting functions

• Operates as Local Safety Officer (LSO) by managing medical safety of assigned local products under the oversight of the Regions Medical Safety Head (this role can be delegated as needed)

• Oversight of the Export Markets managed by India PV team

• Accountable for ensuring PV activities are managed by the Export Market Partners are compliant as per PVA and PV requirements in the perimeter, including promoting actions to make the partner raise to the required compliance levels.

• Manages the India PV team overseeing PV activities for Export Market Partners, if applicable.

Experience:

• Strong experience with PV systems & Regulatory Agency interactions

Soft skills:

• Strong leadership

• Able to create networks and to collaborate in an international cross-functional environment.

• Self–motivated, ruthlessly prioritize to deliver most value.

• Solution oriented & strategic thinking while keeping patients and customers top of mind.

• Good communicator with attention to detail while seeing the big picture.

• Oversight of the Export Markets managed by India PV team: Good persuasion, negotiation and influencing skills, notably for interactions with the Export Market partner PV teams.

Technical skills:

• Strong knowledge of pharmacovigilance systems & regulations

• Good understanding of how to manage safety data from multiple sources

• Able to evaluate & manage safety signals and define risk management activities

Education:

·       Advanced health care discipline degree (MD, PharmD, PhD, Master of Science, etc.) or equivalent qualification

Languages:

Full professional English language proficiency

General competencies

·       As the local Responsible Person for Pharmacovigilance (RPP), the CSH must fulfill the local requirements applicable per country legislation.

·The CSH must demonstrate sufficient proficiency in English (verbal and written) to accurately communicate PV information outside his/her country(ies)

·       Strong knowledge and expertise in national (pharmacovigilance including medical products and vaccines, medical devices, when relevant) regulations and international regulations as well as industry standards.

Key functional competencies

• Medical Safety Landscape

Demonstrates understanding and compliance with the regulatory, therapeutic and clinical environment in order to effectively define and re-evaluate the safety profile throughout the product’s life cycle.

Sufficient ability to interpret clinical data including safety data.

• Signal Detection:  Safety surveillance & data gathering.

Expertise in the collection of drug safety information from a variety of sources throughout the product life cycle to proactively detect and validate potential signals. Continuous evaluating and adopting the most suitable tools to optimize the collection of safety information and detection of signals.

• Signal Assessment & risk identification

Ability to evaluate safety signals to determine causality and impact of signal or risk, risk factors and confounding factors.

• Risk management

Ability to define risk management activities and apply appropriate methods to characterize, avoid or reduce risks to patients and clinical trial subjects when applicable.

• Benefit/Risk assessment & optimization

Throughout the product life cycle, ability to assess identified and potential risks against known and potential benefits for individuals and populations. Skilled in the selection and usage of qualitative and quantitative methods for evaluating benefit/risk balance, depending on the product.

• Insight generation & customer engagement 

Generates and incorporates safety insights to shape the development and commercialization plans, and the broader regulatory environment.

Leadership/Soft skills

• Judgment

The ability to draw logical conclusions based on acquired information or analytical rigour in problem-solving, the ability to make effective decisions even when information is ambiguous or incomplete, to prioritise, develop and evaluate alternate courses of action, to be aware of all the criteria that must be satisfied to address a problem. Demonstrates the ability to focus on short and long term results, as well as the implications of decisions may have on other employees.

• Team leadership

Effective team leadership involves building cohesive, high-performance teams that take accountability and achieve the required outputs.  This requires inspiring cooperation among individuals and teams, placing high priority on goal achievement, and ensuring synergy of effort.  High performing teams demonstrate shared appreciation of the impact and value of coordinated efforts, and eagerness to take accelerated partnership-orientated action. 

• Interpersonal relationships

Interpersonal relationship refers to treating others with courtesy, sensitivity, and respect.  This requires accurately distinguishing individual differences in behaviour, perceptions, and feelings in the workplace.  Employees with strong interpersonal relationships consider and respond appropriately to the needs, feelings, and capabilities of different employees in different situations. 

• Personal leadership

Personal leadership involves the ability to lead from the inside out.  Personal leadership translates into courage, choice, and commitment through the pursuit of excellence, trust and accountability.  Prepared to give up their own interests or wishes in order to help others or advance a cause.

• Drive

Takes the lead and initiates activities with a high degree of passion and commitment. It also refers to a personal positive orientation, together with feelings of enthusiasm, zeal and confidence, as well as the drive, desire and need to achieve challenging goals, to improve performance or to meet personal standards of excellence. 

• Learning agility

A person’s desire and ability to learn from experience, and to apply their learning to perform successfully under new or first-time conditions.

A.Detailed Formal Education and Experience Required:

Education

·       Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPH or master’s degree with two or more years of pharmacovigilance/clinical development experience.

·       Other medical or scientific university educational background may be considered if the candidate has strong experience and other country staff can act as Local Safety Officer.

·       Business degree, e.g., MBA, is a plus.

Experience

·       Experience with pharmacovigilance systems and safety related product management in both clinical development and marketed products

·       Appropriate experience with Regulatory agency interactions

·       Knowledge of required standards for high quality safety relevant documents, e.g., RMP, PBRER

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