46 Drug Safety Associates jobs in India

Job Description

Drug Safety Physician

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization in developed and emerging markets.

We are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk management activities and drive proactive implementation of risk management initiatives to meet global regulatory requirements. The right candidate will have leadership skills, be an excellent communicator with an ability to have oversight over CRO activities and can successfully lead and influence external and internal stakeholders. DSP also serves as a subject matter expert for product-specific safety information.

Responsibilities:

· Contributes to the development & maintenance of product safety profile.

· Involved in all safety surveillance activities, which may include monitoring of adverse event and all other safety information to manage the safety profile of the company products

· Collaborates with, medical monitors and other functional groups in identification, analysis, and reporting of possible safety-related trends or concerns.

· Responsible for the evaluation of safety data from pre-clinical studies, clinical studies, literature and other sources to establish safety profile of company products to manage risk to the patients

· Provides medical input into the identification and utilization of appropriate sources of information and database searches to retrieve relevant data for signal evaluation

· Discuss results of data evaluation with pharmacovigilance safety review team, drug safety committee and/or other key stakeholders

· Provides inputs to literature search strategy and review to effectively determine appropriate and relevant literature for the purposes of safety analysis.

· Responsible for the review of the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) providing expertise to the medical content of the safety specification, risk management plan, risk minimisation measures including the locally implemented risk minimisation measures and drives the implementation of risk minimisation activities in accordance with global regulatory requirements.

· Provides medical input in ensuring that risk minimisation strategies are implemented appropriately in relevant documents such as product reference safety information

· Collaborates with external provider representatives in the preparation and review of aggregate reports having thorough oversight over the critical aspects like summary of safety concerns, benefit risk evaluation, conclusion etc

· Have thorough medical oversight over the external vendors on the medical review of ICSRs

· Provides medical inputs to deliver accurate safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data

· Provides medical inputs in responding to safety questions from regulatory authorities and partners in collaboration with service providers and cross-functional teams

· Review and provides medical inputs to the safety sections of CCDS, local label updates, health hazard analysis, QA trend analysis, device hazard lists, CER etc

· Understands the role of QPPV and contributes to the maintenance of the pharmacovigilance system and process

· Provides inputs to various pharmacovigilance documents like PSMF, SDEA

· Provides input and review for key regulatory or clinical documents (i.e. SMP, protocol, IB, SAE/SUSAR, safety sections of DSUR, ASR, CSR, integrated summaries of safety etc.) related to pharmacovigilance

· Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, signal management, risk management plan preparation and responding to ad-hoc safety questions

· Participates and supports pharmacovigilance audit/inspection preparation and CAPA management

· Participates in internal pharmacovigilance committee meetings as well as joint safety meetings with partners.

· Provides inputs in the preparation/revision of SOPs, working guidance and ensuring pharmacovigilance compliance.

· Meets pharmacovigilance commitments to regulatory authorities with respect to marketing authorization.

· Follows good pharmacovigilance practices (ICH, Eudravigilance, local regulations etc).

· Trains and mentors the team members.

Other Drug Safety Physician responsibilities include:

· Accountable for maintaining personal readiness in response to internal audit or regulatory inspection

· Includes knowledge of case processing, expedited reporting and safety database concepts

· Proactively raises concerns/issues to senior management in a timely and appropriate manner ensures quality and integrity of the issue/event being escalated

· Demonstrates leadership and interacts collaboratively and effectively in team environment (including safety, clinical development, medical affairs,regulatory, commercial, devices) as well as with external stakeholders

· Must be an excellent communicator and have strong negotiation skills with an ability to have oversight over CRO activities

· Strong organisational skills, including capability to prioritise independently with minimal supervision.

Qualifications

· MBBS/PhD/MD with 7+ years of pharmacovigilance experience in the pharmaceutical industry, clinical care setting, or Academia

· Knowledge of the biopharmaceutical industry, drugs and indications with an understanding of applicable guidelines, regulations and best practices for conduct of pharmacovigilance activities.

· High degree of professionalism, maturity, business understanding and passion.

· Strong written and verbal communication skills as well as strong interpersonal skills, with impeccable attention to detail

· Ability to collaborate effectively with internal and external stakeholders at all levels and influence decision-making.

· Must have knowledge of common data processing software like MS office tools (Excel, Power Point, Microsoft Word etc)

Job Location:

Bangalore, India.

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 Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below:

Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.

Education Requirements:

• MBBS and MD (mandatory)
• Candidates without both qualifications will not be considered.

Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.

Education Requirements:

• MBBS, MD(mandatory)
• Medical council of India registration ( Mandatory)

Job Description:

As a Medical Reviewer – Pharmacovigilance , you will be responsible for the comprehensive medical review of individual case safety reports (ICSRs) and ensuring compliance with regulatory and client-specific requirements. You will play a critical role in safeguarding patient safety through high-quality medical evaluation and regulatory reporting.

Key Responsibilities:

• Perform medical review of ICSRs for accuracy , medical relevance , and consistency with the source documents and safety database entries, in alignment with client requirements.
• Conduct second-level triaging of non-serious cases to identify any potential serious adverse events (SAEs), as per client-specific conventions.
• Review and validate:
• Suspect product coding
• Event selection and MedDRA coding (current version)
• Grouping/subsuming and event ordering
• Confirm and correct:
• Event coding and classification
• Ranking of events, seriousness criteria, and listedness/expectedness
• Perform comprehensive medical evaluation of adverse event reports including serious/expedited cases and pregnancy-related reports.
• Assess adverse events for seriousness , listedness , and causality , ensuring all medically relevant data from source documents is accurately reflected.
• Review and enhance narratives in compliance with client conventions.
• Provide or verify company pharmacovigilance (PV) comments as needed.
• Initiate appropriate follow-up queries based on the clinical context of the case.
• Identify and escalate potential safety signals or concerns in line with client procedures.
• Ensure completeness and medical soundness of cases before providing final medical sign-off .
• Assess malfunctions and serious injury/death outcomes in relation to combination products.
• Participate in literature surveillance and aggregate report medical review, ensuring compliance with regulatory timelines and SOPs.
• Track and document inconsistencies in data entry and provide feedback for continuous improvement.
• Collaborate closely with cross-functional teams to maintain scientific accuracy , clarity , and regulatory compliance in all case documentation.
• Stay updated with international pharmacovigilance regulations and follow all applicable SOPs , guidelines , and best practices .
• Attend mandatory internal and client-specific trainings to ensure continuous compliance.

Required Skills and Competencies:

• Strong analytical and critical thinking abilities
• High attention to detail and scientific accuracy
• Sound medical judgment and decision-making in line with pharmacovigilance standards
• Proficiency in medical terminology , disease pathology, pharmacology, and therapeutics
• Ability to analyze and interpret adverse event data
• Strong written and verbal communication skills
• Good comprehension and the ability to summarize complex medical data
• Team player with effective interpersonal and collaboration skills
• Familiarity with pharmaceutical industry practices and drug development processes (preferred)

Additional Requirements:

• Willing to relocate to any of the listed office locations.
• Ready to work from the office with hybrid options
• Must possess MBBS and MD degrees (non-negotiable)

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.

• Collect, process, and evaluate adverse event (AE) reports from various sources, including spontaneous reports, clinical trials, and literature.
• Ensure accurate and timely data entry into safety databases, adhering to company standards and regulatory requirements.
• Assess the causality of reported events and perform medical coding (e.g., MedDRA) as per guidelines.
• Prepare aggregate safety reports (e.g., PBRERs, DSURs) in collaboration with medical safety physicians.
• Monitor safety signals and contribute to signal detection activities.
• Communicate with healthcare professionals, patients, and regulatory authorities regarding safety inquiries and reporting obligations.
• Maintain compliance with global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).
• Assist in the development and review of safety-related documents, such as Investigator's Brochures and Risk Management Plans.
• Participate in internal and external audits and inspections related to pharmacovigilance activities.
• Collaborate with cross-functional teams, including regulatory affairs, clinical operations, and medical affairs.
• Contribute to the continuous improvement of pharmacovigilance processes and systems.
• Stay updated on evolving regulatory requirements and industry best practices in drug safety.
• Manage safety database queries and ensure data integrity.
• Support the training of new team members on pharmacovigilance processes.

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field. A Master's degree or relevant professional certification (e.g., QPPV, CSP) is a strong asset.
• Minimum of 3 years of experience in drug safety, pharmacovigilance, or clinical safety data management.
• Thorough understanding of global pharmacovigilance regulations and reporting requirements.
• Proficiency with safety databases and pharmacovigilance software.
• Strong knowledge of medical terminology and coding dictionaries (e.g., MedDRA, WHO-ART).
• Excellent analytical, critical thinking, and problem-solving skills.
• Exceptional attention to detail and accuracy in data handling.
• Strong written and verbal communication skills, with the ability to articulate complex safety information clearly.
• Proven ability to work independently, manage time effectively, and meet strict deadlines in a remote work environment.
• Experience with data analysis and report generation.
• Familiarity with clinical trial processes is a plus.

Designation : Safety Aggregate Reporting Manager

Skill: Authoring Aggregate reports

Experience: 7+

Location : Across PAN India

Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including but not limited to safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project/client initiatives. Ensure team is following standard best-in-class practices established by the SARA infrastructure

• Serve as a stand-alone global lead for aggregate reporting, signal management.
• Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSURs,

DSURs, PADERs, RMPs, REMS, ACOs, line listings

• and author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
• Act as literature lead, back-up lead, reviewer/QCers to conduct ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data &/or signal detection relevance review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines.
• Act as Signal Management Lead on large and/or complex post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Serve as subject matter expert across projects for complex data mining methodogies and algorithms on internal and external safety datasources. Oversee/set-up and update products' signaling strategies. Oversee/author and/or QC review all types of signal management deliverables.
• Oversee/conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Accountable for full documentation and tracking of signals. At project level, maintain compliance, prepare metrics and KPI, present at audits and inspections.
• In a PV support role, act as functional lead and oversee/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
• Provide training to SARA staff for qualification on SARA deliverables
• May perform quality check of all assigned SARA deliverables
• be responsible for the quality of the final SARA deliverable to client regulatory, IQVIA regulatory reporting (RR), and regulatory authorties.
• Provide consultative guidance to internal and external stakeholders in the for all SARA deliverables.
• Act as mentor to and coach to project team staff and direct line reports.

Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP),