EY RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Manager 

India, West Bengal, Kolkata 

495130845

Your key responsibilities

• Manage multiple pharmacovigilance projects, ensuring they are delivered on time, within scope, and budget.
• Coordinate with cross-functional teams to ensure seamless integration of PV activities with other services.
• Monitor project progress and make adjustments as necessary to meet client expectations and regulatory requirements.
• Stay abreast of global pharmacovigilance regulations and guidelines and ensure all PV activities are compliant.
• Provide expert advice on regulatory strategy, risk management, and post-marketing surveillance.
• Assist clients with regulatory submissions, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
• Manage and mentor a team of pharmacovigilance professionals, fostering a culture of excellence and continuous improvement.
• Conduct training sessions on pharmacovigilance principles and practices for team members and clients.
• Participate in the recruitment and development of pharmacovigilance staff.
• Manage and mentor a team of pharmacovigilance professionals, fostering a culture of excellence and continuous improvement.
• Conduct training sessions on pharmacovigilance principles and practices for team members and clients.
• Participate in the recruitment and development of pharmacovigilance staff.
• Serve as the primary point of contact for clients regarding pharmacovigilance and drug safety issues.
• Develop and maintain strong client relationships, understanding their needs and providing tailored solutions.
• Lead client meetings and presentations, and ensure client satisfaction with the services provided.
• Regular status reporting to the Senior Managers, Partners, Directors and onsite coordinators.

Skills and attributes for success

• In-depth knowledge of pharmacovigilance principles, drug safety processes, and adverse event reporting. Understanding of the drug development lifecycle and post-marketing surveillance is crucial.
• Familiarity with global regulatory requirements and guidelines related to pharmacovigilance (e.g., FDA, EMA, ICH guidelines).
• Proficiency in analysing safety data and interpreting trends. Experience with databases and software tools used in pharmacovigilance (e.g., Argus, ARISg).
• Ability to provide strategic advice, problem-solving, and support to clients. This includes understanding client needs, developing tailored solutions, and maintaining client relationships.
• Developed pharmacovigilance system master file (PSMF) with the legal requirements and verify that the information contained in the PSMF is an accurate and up-to-date reflection of the pharmacovigilance system.
• Sound domain knowledge in pharmaceutical industry mainly into safety profiling and any emerging safety concerns for the products for which the company holds a Marketing Authorization.
• Awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products.
• Hands-on experience in the creation of Risk Management Plan (RMP).
• Worked on submission of all pharmacovigilance-related documents in accordance with the legal requirements.
• Provided input into the preparation of regulatory action in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and communication to patients and healthcare professionals)
• Strong knowledge on signal detection, periodic benefit/risk analysis, risk management plan.
• Has worked on Submission of Periodic Safety Update Reports (PSURs) for MAH approved medicinal products.

To qualify for the role, you must have

• B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 10-12 years of experience with Big 4 or Multi-National Regulatory Compliance companies.
• A degree in pharmacy, medicine, nursing, life sciences, or a related field is also considered. Advanced degrees (e.g., PharmD, MD, PhD) can be advantageous.
• Good interpersonal skills; Good written and presentational skills
• At managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations
• Experience in managing team and solution designing

Ideally, you’ll also have

• Extensive experience in pharmacovigilance or drug safety within the pharmaceutical industry. Certified Pharmacovigilance Professional (CPVP)
• Strong knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).
• Excellent analytical and problem-solving skills.
• Strong leadership and team management abilities.
• Proficiency in pharmacovigilance databases and software. Prior experience with safety database systems (e.g., Argus, ARISg) and safety signal detection tools is desirable.

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role

with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• Support, coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way that’s right for you

EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets.