Lead - Medical Monitoring & Safety

Key Responsibilities:

• Review and provide medical oversight for clinical study documents, including Protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), Investigator's Brochures (IBs), and Clinical Modules.

• Contribute to the preparation and review of clinical safety narratives, including CSR narratives, regulatory submission narratives, and safety-related medical documents.

• Perform medical review of adverse events (AEs), serious adverse events (SAEs), medical coding (MedDRA/WHO Drug), concomitant medications, prior medications, and causality assessments.

• Provide medical input into study design and conduct, including CRF review, Medical Monitoring Plans, Protocol Deviation (PD) management, eligibility criteria assessments, laboratory manuals, imaging plans, and other study-specific medical documents.

• Support investigator meetings by participating in medical presentations, protocol discussions, and study-specific training activities.

• Serve as the primary medical contact for study-related queries from study sites, clinical operations teams, ethics committees (IRBs/IECs), and cross-functional stakeholders.

• Conduct protocol and therapeutic area training for internal study teams, investigators, and study personnel to ensure consistent understanding of study requirements.

• Review Safety Management Plans, DSURs, PSURs, Risk Management Plans (RMPs), Annual Safety Updates, Medical Review Manuals, and other pharmacovigilance and regulatory safety documents.

• Perform medical review and assessment of CIOMS/ICSRs, ensuring medical accuracy, completeness, and compliance with applicable regulatory requirements.

• Support SAE management activities, including follow-up of safety events, medical evaluation, and coordination with investigational sites and pharmacovigilance teams.

• Provide medical oversight for data review activities, including review of listings, trends, safety signals, TLFs (Tables, Listings, and Figures), and medically significant data discrepancies.

• Facilitate interactions with Key Opinion Leaders (KOLs) and Therapeutic Area Experts (TAEs), organize and participate in scientific advisory meetings, and contribute to clinical and scientific discussions.

• Maintain and demonstrate expertise in relevant therapeutic areas and provide ongoing scientific and medical guidance to project teams.

• Collaborate with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, and other stakeholders to ensure high-quality study conduct and regulatory compliance.

• Provide medical leadership and support for assigned clinical development projects and undertake additional project-related responsibilities as delegated by management.

Educational Qualification

MBBS with M.D. Pharmacology/Medicine or full-time post-graduate qualification in any discipline of medicine

Minimum Work Experience

2-4 years of experience in the pharmaceutical industry or research company in a Medical Advisor capacity

Knowledge & Skills

• Experience in clinical research, medical monitoring, pharmacovigilance, medical affairs, or clinical development preferred.

• Strong understanding of ICH-GCP, CDSCO, FDA, EMA, and other applicable regulatory requirements.

• Experience in protocol review, medical data review, safety assessment, and medical monitoring activities.

• Knowledge of adverse event evaluation, medical coding (MedDRA/WHO Drug), and safety reporting requirements.

• Excellent scientific writing, presentation, and communication skills.

• Ability to work effectively in cross-functional and matrix team environments.

• Strong analytical, medical judgment, and problem-solving skills.

• Therapeutic area expertise in relevant disease areas will be an added advantage.

Behavioural Skills

Integrity-driven decision-making skills.

Sound scientific knowledge.

Collaboration and teaming with the ability to work in a matrix environment.

Strategic thinking & sound analytical skills.

Intellectual curiosity.

Self-awareness and adaptability to work in a matrix environment.

Result-oriented and performance-driven.

Excellent interpersonal & communication skills to effectively interact with a broad range of audiences.

About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon.

With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.

With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.

Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.

We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure

Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.

Benefits Offered

At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

For more details, please visit our career website at https://careers.drreddys.com/#!/