About the job
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
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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.
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If this excites you, then apply below.
Job Description
Manager-Pharmacovigilance Operations
· To manage the day-to-day operations within the PV department and liaise with the team and management to ensure effective functioning of the department and address any concerns or issues.
· Drive high client satisfaction, guide the team, provide timely feedback to the team members, review write proposals, provide project status, build mastery and remain current with regulatory requirements.
· Identify opportunities for process optimization, efficiency gains, and enhanced quality in pharmacovigilance activities. Propose and implement improvements to enhance operational effectiveness and ensure adherence to best practices.
· Oversee the end-to-end process of adverse event case management, including case intake, data entry, triaging, and follow-up.
· Anticipate challenges, identify opportunities for improvement, and contribute to the development of long-term pharmacovigilance strategies.
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SKILLS:
· Cognitive abilities including verbal reasoning, attention to detail, critical thinking, scientific accuracy, and analytical ability.
· Good comprehension skills.
· Good communication and interpersonal skills.
· Knowledge of disease mechanisms and physiology, drug mechanisms of action and therapeutics.
· Familiarity with pharmaceutical industry principles of drug development and pharmacovigilance is preferred but not required.
· Advanced knowledge of pharmacovigilance regulations, guidelines, and best practices is necessary.
· Familiarity with adverse event reporting, safety signal detection, and benefit-risk evaluation is crucial for effective medical review.
· Ability to independently solve routine problems related to core case processing and surface issues constructively with minimal oversight from manager.
· Ability to discern when additional input is required to effectively address unique and/or complex situations.
· Ability to work independently to accomplish team goals with minimal supervision.
· Should be able to streamline workflows, optimize resource allocation, and enhance operational effectiveness.
PRINCIPAL RESPONSIBILITIES:
· Provide oversight for overall program schedule and resourcing.
· Provide SME and process oversight for operational activities.
· Act as single-point of contact for all functional lines being supported.
· Manage, direct and control PV team, responsible for the evaluation and consistent handling of adverse events, ensuring compliance with reporting timelines and quality standards.
· Manage and liaise with team and ensure that all tasks are performed according to business rules, guidelines, and standard operating procedures.
· Monitor workload and ensure Leads allocate work appropriately.
· Ensure that incoming reports are reviewed by the team according to internal timeframes.
· Monitor the quality of work produced by the team and support quality improvement initiatives as appropriate.
· Discuss and set up development plans with/for all team members to further develop individual’s skills and potentials.
· Set up the training plans for new hires according to the individual’s experience and job role and ensure that training is provided to team as appropriate.
· Review, author and update Standard Operating procedures and support in global initiatives for ensuring enhanced quality and compliance. Involve in retention strategy and ensure associate engagement.
· Communicate the observations to the applicable stakeholders and ensure the appropriate Root Cause Analysis/ Corrective Action and Preventive Action.
· Contributes to the preparation of metrics and custom reports for clients.
· Oversee reconciliation reports.
· Communicate and interact effectively within and across all client key stakeholders and within internal team management as appropriate.
· Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines.
· Be responsible for all content milestone deliverables, namely, quality and accuracy, timeliness, and efforts.
· Convey client requirements and review the work done by the team members in terms of the information flow and presentation; provide feedback and conduct their performance appraisals.
TEAM MANAGEMENT:
· Educate the team (both existing and new members) on maintaining confidentiality and copyright rules as per clients and company norms.
· Execute and propel quality systems, processes, and policies.
· Liaise with internal auditors to follow and ensure execution of corrective action and compliance to specification.
· Identify the quality training needs for various requirements and take action to comply with the same.
· Monitor performance by collating and analyzing performance data and charts against defined parameters.
· Bring together staff of different resource groups and drive the group to plan, formulate and agree to comprehensive quality procedures for clients and specific projects.
EDUCATION: Bachelor’s degree in pharmacy, dentistry, nursing, or equivalent, Master’s degree from life sciences background or Bachelor of Medicine and Bachelor of Surgery [MBBS] or Doctor of Medicine [MD] or Doctor of Surgery [MS].
EXPERIENCE: 13-17 years of experience in Pharmacovigilance inclusive of 7-8 years of experience in managing and leading a team.
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.
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