Title:  Lead - Scientific Writing

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to 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 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 believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.

We are a 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.

Lead - Scientific Writing

Job Description:

We seek an ambitious and energetic Medical Reviewer to join our Safety team! The successful candidate will be responsible for performing medical review (seriousness, expectedness, causality assessment) and oversight of pharmacovigilance activities, including ICSRs, literature surveillance, signal management, periodic aggregate reports, risk management planning, risk/benefits evaluations, and provide the required medical insight at all stages of safety deliverables.

Responsibilities:

• Carrying out medical review, including assessment of seriousness, expectedness/listedness, and causality of adverse events reported for investigational and marketed products, and ensuring compliance with reporting timelines and quality standards.
• Medical Review and oversight of ICSRs and literature surveillance as a part of pharmacovigilance activities and for aggregate reports for the purpose of expedited/periodic submission as per the Regulations and SOPs.
• Involved in identification of potential signals requiring further assessment based on review of all sources, performance of signal detection and validation as per guidelines in SOP, and providing signal data for aggregate reports.
• Responsible for the medical review and provision of oversight for completeness, accuracy, and overall medical content of periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports.
• To ensure medical and clinical integrity of data with correct interpretation without missing any medical information from the source document.
• Contribute to pharmacovigilance and risk management planning for designated products by preparation of safety surveillance strategy and tracking and evaluating potential issues.
• Review safety assessments, risk/benefits evaluations, provide inputs and value add from medical perspective at all stages of safety deliverables.
• Responsible to participate in assigned training programmes relevant to the job
• Control/reduce the cost, cycle time and error rates in projects
• Interface with clients on a regular basis to meet their expectations, when required

Qualifications:

• Medical (M.B.B.S/MD/MS/DNB)

If you are a highly motivated individual with a passion for communication and a desire to make a difference in the healthcare industry, we encourage you to apply for this exciting opportunity.

Your impact:
About you:

• Minimum 3 years of relevant experience or its equivalent within Pharmacovigilance, hospital or pharmacy; familiarity with clinical assessment an advantage, with at least 1 year of experience of medical review of aggregate reports.

Must have:

• Knowledge of regulatory documentation, drug development process and global regulations and guidelines.
• Knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
• Knowledge of regulatory documentation, drug development and global regulations and guidelines.
• Good written and verbal communication skills.
• Good organizational and time management skills.
• Good attention to detail and decision-making skills.

Nice to have:

• Strong interpersonal skills and the ability to be flexible in varying environments

• Good mentoring skills.

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.