Senior Operations Manager-Pharmacovigilance

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it? We understand that you are looking for growth and variety in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We hire the best and trust them from day 1 to deliver global impact, handle teams and be responsible for the outcomes while our leaders support and mentor you. We are a profitable rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you. If this excites you, then apply below. Senior Operations Manager-Pharmacovigilance Job Summary: As an Operations manager you will be responsible to manage the delivery & operations of large engagements. Would be responsible for providing direction and driving high client satisfaction by planning and managing timely and quality deliveries. The customer team as well as Indegene members are spread across geographies (US, the EU and India). The primary mandate would be to ensure that all customer requirements are met in a cost effective, timely and compliant manner. Job Description: Operations management - Pharmacovigilance Provides oversight, review and monitor compliance to client requirement and Regulatory requirement through various monitoring reports and other oversight activities. Establishes oversight procedures and Key Performance Indicators (KPIs). Generates metrics and provides feedback on a regular basis Participates in internal/client audits and global regulatory inspections as a SME for specific PV topics and processes. Adheres to company policies and applicable regulations including reporting of adverse events to regulatory agencies Provides direct technical /data management support to ensure information entered and retrieved from the safety database is consistent, accurate and complete in accordance with data requests. Perform ad hoc analyses as required Manages and assists in implementing and maintaining a comprehensive risk based GVP/GCP compliant quality program/systems Provides input to GVP related Corrective and Preventive Action plans. Identify and remediate performance issues to maintain a state of high PV inspection readiness. Escalates critical and major PV gaps to the management to ensure appropriate action. Maintains and participates in PV training of employees on their safety reporting responsibilities. Proficient in effectively running day to day operations Demonstrates proficiency to define the scope, estimate, plan and monitor and review projects to closure as per the expectations. Ability to understand how decisions affect the bottom line, knows about general financial and accounting principles and practices that affect operations, understands the procedures of the financial management, such as: financial authority level and approval process, budgeting, monitoring, reporting, etc. Demonstrates proficiency in understanding client requirements, effectively communicates effort estimates, develop solutions to formulate robust winning strategy. People Management & Team development: Fosters employee growth by providing a supportive learning and development environment Demonstrates proficiency in managing large team. Shares experiences for constructive outcomes. Enables team members to discuss their aspirations, goals and shortcomings and develops plans to address these Provides honest, timely, constructive and specific feedback on performance, even if it is a hard feedback, leading to true development Problem solving and business acumen: Understands the problem from multiple dimensions. Solves problems in a timely fashion by generating and assessing options, evaluating implications and implementing solutions thoroughly Identifies and executes financial drivers of own function to enhance profitability/productivity/ market share for business growth Continuously seeks information from current clients and prospects to understand emerging needs and make meaningful interpretations Desired Profile Min 14+yrs of exp in operation management & 5+yrs of exp in client facing role and direct pharmacovigilance work experience in the pharmaceutical industry, post graduate from premium B schools will be a plus Strong managerial experience including the ability to coach, communicate expectations and praise accomplishments with the team. Strong knowledge of electronic systems used to manage clinical trial data and safety reporting (i.e. eTMF, EDC, Argus, ArisG, IVRS), and knowledge on MedDRA, WHO DD dictionaries. Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize clinical and safety data Superior communication skills Should have managed large teams Proficient in financial concepts. Previous experience and formal training with safety database programs including configuration and validation activities is desired. Ability to deal with multiple stake holders and manage client’s expectations Ability to take initiatives with excellent interpersonal skills Good negotiation skills Passion for networking and updating oneself with the latest market trends and relate it to identifying business opportunities Structured thinking and articulation Ability to manage pressure and work with multiple stakeholders EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.