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),

Job Overview



The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the products safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.


Essential Functions



Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary
Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical data
Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable
Provide aggregate reviews of safety information, including but not limited to clinical data, post marketing, literature review and observational studies to maintain oversight of a products safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)
Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective.
Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment.
Ensure update of watch list, list of expectedness, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team
Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives
Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable
Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable
Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable
Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable
24-hour medical support as required on assigned projects
Maintain awareness of medical safety-regulatory industry developments
Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable


Qualifications

MBBS OR MD from an accredited and internationally recognized medical school with a curriculum relevant to general medical education is required.
Three plus (3 + years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training is required.
Two plus (2+) years of pharmacovigilance experience is required.
Sound knowledge of Medicine
In-depth knowledge of applicable global, regional and local clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Knowledge of Pharmacovigilance- ICSR.
In-depth knowledge of departmental standard operating procedures (SOPs)
Skill in use of multiple safety databases
Adequate Computer skills, especially Microsoft word, excel & PowerPoint
Good communication skills- verbal and written
Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives
Ability to establish and maintain effective working relationships with coworkers, managers and clients
A valid medical license, or equivalent, from the country or region in which he/she resides and works preferred.

Biocon is seeking a skilled Regulatory Affairs Specialist to support global biologics submissions and regulatory compliance. The role involves preparing, reviewing, and compiling dossiers (CTD/eCTD), managing product life-cycle submissions, and ensuring alignment with international regulatory requirements (US, EU, ROW). The ideal candidate has hands-on experience in biologics or biosimilars regulatory filings, excellent documentation skills, and strong collaboration with cross-functional teams (QA, QC, R&D, Manufacturing).

Location: Bengaluru, India
Experience: 410 years
Qualification: M.Pharm / M.Sc (Biotech / Life Sciences)

About the Role:

We are seeking an experienced professional in API Regulatory Affairs with strong expertise in DMF preparation, compilation, and submission for global markets (US, EU, Canada, Japan, and ROW). The role involves ensuring compliance with regulatory requirements and supporting global submissions for Active Pharmaceutical Ingredients.

Key Responsibilities:

Prepare, compile, and review Drug Master Files (DMFs) and related regulatory documentation for global submissions.

Handle query responses from regulatory agencies in a timely manner.

Coordinate with cross-functional teams including QA, QC, R&D, and Manufacturing for data collection.

Maintain regulatory compliance and ensure updates/amendments of DMFs as per market requirements.

Support audits and provide documentation as per global regulatory expectations.

Track and maintain regulatory submissions and lifecycle management of DMFs.

Required Qualification & Experience:

Qualification: M.Sc. / M.Pharm (Chemistry / Pharmaceutical Sciences preferred)

Experience: 7 15 years in API Regulatory Affairs with hands-on experience in DMF compilation and global submissions

Key Skills:

Expertise in USDMF / EDMF / CEP filing

Knowledge of ICH guidelines, regulatory frameworks, and dossier requirements

Strong documentation and communication skills.

Prepare, review, and compile CMC (Chemistry, Manufacturing, and Controls) sections of regulatory dossiers for peptide and injectable formulations.

Manage submissions for ANDA, NDA, DMF, CTD/eCTD formats for global markets (USFDA, EMA, WHO, etc.).

Ensure timely regulatory approvals, renewals, and variations.

Evaluate and interpret regulatory guidelines for peptides and sterile dosage forms to ensure compliance.

Liaise with R&D, QA, QC, Manufacturing, and Project Management teams to support product development and lifecycle management.

Maintain up-to-date knowledge of global regulatory requirements for peptides and injectables.

Handle queries from health authorities, provide technical justifications, and support audit readiness.

Oversee labeling, packaging, and artwork approvals for regulatory submissions. Education: M.Pharm / M.Sc in Pharmaceutical Sciences, Chemistry, or related field.

Experience: 812 years in Formulation Regulatory Affairs, with at least 35 years in peptide or injectable products.

Strong knowledge of CMC documentation, eCTD submissions, and regulatory databases.

Experience in USFDA, EMA, and other international regulatory filings.

Excellent understanding of ICH, WHO, and country-specific guidelines.

Proficient in technical writing, data interpretation, and document review.

Strong interpersonal, communication, and leadership skills.

About the Role

Genpact is seeking an experienced Senior Data Modeler with deep expertise in data architecture and modeling within the Life Sciences domain. The ideal candidate will design, develop, and optimize complex data models to support analytics, regulatory reporting, and digital transformation initiatives across pharmaceutical and healthcare clients.

Key Responsibilities

Design and implement conceptual, logical, and physical data models for life sciences data ecosystems (clinical, commercial, safety, regulatory, etc.).

Collaborate with business stakeholders, data architects, and engineering teams to translate business needs into scalable data solutions.

Ensure data model alignment with industry standards (CDISC, SDTM, IDMP, HL7, etc.) and regulatory compliance requirements.

Support ETL/ELT design and data integration across multiple platforms (Snowflake, AWS, Azure, GCP, Databricks).

Maintain and optimize data dictionaries, metadata, and master data models.

Provide data governance guidance and enforce best practices for data quality and consistency.

Mentor junior data modelers and provide architectural oversight on key client engagements.

Partner with data scientists, data engineers, and analytics teams to enable advanced insights and AI/ML-driven decision-making. Required Skills & Qualifications

Bachelors or Masters degree in Computer Science, Information Systems, Life Sciences, or related field.

1018 years of total experience with at least 6+ years in data modeling or data architecture roles.

Strong hands-on experience with ER/Studio, ERwin, PowerDesigner, or similar tools.

Expertise in SQL, data warehousing, and dimensional modeling (Star/Snowflake schema).

Proven experience in Life Sciences or Healthcare data domains (Clinical, R&D, Pharmacovigilance, Commercial, Regulatory).

Familiarity with cloud data platforms (Snowflake, AWS Redshift, Azure Synapse, GCP BigQuery).

Excellent communication, stakeholder management, and documentation skills.

Preferred Qualifications

Experience with data lake / lakehouse architectures.

Knowledge of data governance tools (Collibra, Informatica Axon, Alation).

Certification in cloud technologies (AWS/Azure/GCP) is a plus.

Exposure to AI/ML pipelines and data lineage frameworks.

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 thats 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 Indegenes high-speed growth. We are purpose-driven. We enable healthcare organizations to 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.

Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.

As the Senior Aggregate Safety Report Lead, you will take ownership of global aggregate safety deliverables for one or more products (or portfolios) across investigational and marketed life-cycle phases. You will lead the preparation, review and delivery of safety aggregate reports (e.g., PBRERs, PSURs, DSURs, PADERs, RMPs) and will be responsible for signal management, literature surveillance and benefit-risk assessments. You will interface with clients, regulatory authorities and cross-functional teams, ensuring high-quality, timely compliance and continuous improvement of processes. Act as the lead/owner of SARA deliverables: author, review, finalise and deliver aggregate safety reports (e.g., PBRERs/PSURs, DSURs, PADERs, RMPs, ACOs, line listings) in compliance with applicable Service Level Agreements (SLAs) and regulatory requirements. Lead signal management: establish, implement and monitor signal detection strategies; perform signal validation, evaluation, documentation, track signals, and contribute to benefit-risk evaluation.Manage cross-functional collaboration: work closely with Regulatory Affairs, Medical Writing, Quality, Real-World Evidence/late phase, Clinical Research, Safety Operations, Project Leads and client stakeholders.

As a Safety Aggregate Report Specialist 2, you will play a key role in ensuring compliance with global pharmacovigilance regulations by authoring, reviewing, and managing high-quality aggregate safety reports (ASRs) such as Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Periodic Benefit-Risk Evaluation Reports (PBRERs).
You will collaborate cross-functionally with clinical, regulatory, and safety teams to ensure timely submission of regulatory reports in accordance with ICH and local requirements. Bachelors or Masters degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or related field.

3 8 years of experience in pharmacovigilance or aggregate report authoring.

Strong understanding of global regulatory guidelines (ICH, EMA, FDA, MHRA, etc.).

Excellent writing, analytical, and interpretation skills for clinical and safety data.

Familiarity with MedDRA coding, Argus/ARISg, and safety databases is preferred.