Qualification & ExperienceEligibility Criteria: Candidates with minimum 3+ Yrs of experience in Bio- Chemistry & Microbiology with an NABH accredited Hospital .

ResponsibilitiesAggregate Safety Reports & Documentation: Independently lead the preparation/update of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions, including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overviews (ACOs), Investigational New Drug Annual Report (INDARs), Semi-Annual Safety Reports (SASRs), Annual Risk- Benefit Evaluation (ARBE) report , Safety statements, Health Hazard Evaluation (HHE), Clinical Overview (CO) and any other ad hoc safety documents, ensuring scientific accuracy, regulatory compliance, and timely delivery. Serves as an SME for safety reports, developing templates, guiding teams, and creating strategies to address complex regulatory and data presentation challenges. Facilitate operational coordination, including scheduling and leading meetings, drafting agendas and minutes, tracking action items, and ensuring timely follow-up on open issues to support seamless project execution. Ensure compliance and quality across aggregate safety reports, performing detailed reviews for factual accuracy and internal consistency across documents such as but not limited to PBRERs, DSUR etc.). Manage the distribution of final reports to stakeholders, including partners, affiliates, and health authorities, in accordance with agreed timelines, distribution lists, and email templates (as required). Safety Analysis & Signal Management: Leads advanced safety signal detection and management for key products, integrating diverse data sources and innovative analytical approaches to identify emerging safety concerns. Provides expert interpretation of complex safety data patterns and trends across product lifecycles. Leads clinical safety activities for complex molecules, contributing to strategic decisions as part of the global safety team. Collaborates with cross-functional teams to analyze complex safety data and provide support as part of the study management team. Directs literature review strategies and critically evaluates scientific evidence for inclusion in safety documents. Leads safety evaluations for complex molecules and sensitive indications, providing scientific direction that supports clinical strategy and strengthens regulatory positioning through high-quality safety reports and responses. Qualification & Experience    Preferred qualifications include a university degree in Life Sciences, Health, or Biomedical Sciences—such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy etc. Or equivalent combination of training and work experience. Clinical exposure in hospital-based environments is considered advantageous.Strong analytical and problem-solving abilities, with the capability to independently evaluate complex data and draw meaningful conclusions. Exceptional communication skills, both verbal and written, including the ability to produce clear, concise, and accurate medical/scientific content. Excellent interpersonal and collaboration skills, fostering productive relationships with clients, cross-functional teams, and stakeholders. Effective organizational and prioritization skills, with the ability to manage multiple tasks enthusiastically and maintain attention to detail under tight timelines. Client-focused mindset, demonstrating flexibility, professionalism, and a proactive approach to meeting client expectations and expanding business opportunities. Strong negotiation and stakeholder management skills, ensuring alignment of resources, timelines, and deliverables across teams and departments. Cultural awareness and adaptability, enabling effective communication and collaboration in global, multicultural environments. Proficient in computer operations and IT tools, with expertise in web-based applications and familiarity with the Windows operating system and Microsoft Office suite (Word, Excel, PowerPoint). Knowledge and Experience: Prior experience in pharmacovigilance, or related fields is preferred. Demonstrates Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts.:

ResponsibilitiesAggregate Safety Reports & Documentation: Leads the preparation of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions, including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overviews (ACOs), Investigational New Drug Annual Report (INDARs), Semi-Annual Safety Reports (SASRs), Annual Risk- Benefit Evaluation (ARBE) report , Safety statements, Health Hazard Evaluation (HHE), Clinical Overview (CO) Develops strategic approaches for challenging safety submissions, incorporating innovative data presentation techniques to enhance clarity and regulatory impact. Reviews and approves high-complexity safety documents, ensuring scientific accuracy, regulatory compliance, and alignment with product strategy. Coordinates multi-document submissions, ensuring consistency and integration across safety documentation packages. Provides expert guidance on evolving global regulatory requirements and advises on their implications for safety documentation. Manages meeting logistics including scheduling, agenda drafting, minute preparation, and tracking of action items, ensuring timely follow-up and resolution of open issues. Safety Analysis & Signal Management:Designs and implements advanced signal detection plans tailored to specific product profiles and diverse data sources. Leads signal detection for priority products by conducting expert-level analyses to uncover subtle safety signals and complex data patterns. Develops robust literature review strategies and critically evaluates complex scientific evidence or inclusion in PSRs, drug safety reports, and RMPs. Supports clinical safety and ad-hoc safety activities for complex molecules, contributing to strategic safety evaluations. Authors and reviews high-priority signal assessment reports and health authority response documents, resolves data challenges, and enhances decision-making through expert analysis and innovative visualizations. Risk Management Plan:Leads the preparation, updating, and integration of Risk Management Plans (RMPs) and Company Core-RMPs (CC-RMPs) across multiple regulatory regions and product types, ensuring alignment with evolving safety profiles and strategic objectives. Prepares and handles reviews of health authority response documents, incorporating safety data and regulatory insights to address queries and support submissions of RMPs. Oversees Reference member state (RMS) updates, ensuring consistency with client conventions, global regulatory expectations, and internal SOPs. Provides strategic input on risk minimization measures and benefit-risk communication, tailoring content to diverse regulatory audiences. Collaborates with cross-functional teams to ensure RMPs are scientifically robust, compliant, and aligned with the overall safety strategy. Qualification & Experience    Preferred qualifications include a university degree in Life Sciences, Health, or Biomedical Sciences—such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy etc or equivalent combination of training and work experience. Clinical exposure in hospital-based environments is considered advantageous. Demonstrates advanced analytical thinking and problem-solving skills to interpret complex safety data and derive meaningful conclusions to support benefit-risk assessments. Possesses strong scientific writing and communication capabilities, ensuring the production of clear, accurate, and regulatory-compliant documents. Strong capability to lead and collaborate across cross-functional, global teams and build trusted client relationships. Excels in organizational and time management, with the ability to prioritize tasks, manage multiple high-impact projects, and consistently meet deadlines. Proficient in medical writing tools and MS Office applications, with working knowledge of pharmacovigilance databases and coding dictionaries such as MedDRA and WHO-DD. Proactive in adopting new technologies, driving process improvements, and applying innovative approaches to safety documentation. Knowledge and Experience: Prior experience in pharmacovigilance, or related fields is preferred. Demonstrates Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts.

ResponsibilitiesResponsible for maintaining Microbiology laboratory in a State of All time Audit readiness. Responsible for Review of GLP documents like List of instruments, Calibration Schedule, AMC schedule, Trends, Annual summary but not limited to in both microbiology laboratories. Initiation & Investigation of Microbial Excursions, OOS, deviation, change control, Incident related to QC- Microbiology and cross functional Team. To ensure & testing, reporting & timely release of Microbiological samples like SFG, FG, Raw materials, In process, Intermediate, stability and packing materials, compressed air, swab samples of OSD facility, Inhaler & foam facility and Nasal facility. To ensure Periodic requalification of instrument/ equipment. Execution of Microbiological method validation verifications/ Miscellaneous studies. To ensure the working area / instruments cleanliness, and proper filing of documents and storage of the same at the respective place. Up keeping the all documents of with online entries. Maintain the ATR in Microbiology laboratory. Procurement, receipt, revival and maintenance of standard cultures. Identification and maintenance of isolated microbial cultures. Up keeping of all the documents with online entries. Review of all analytical and related documents like logbooks, TDS, protocol, report but not limited to. Review of all analytical and related documents like logbooks, TDS, protocol, report and SOPs but not limited to. Responsible to face internal and external inspection and provide compliance to audit observations. Act as an SME for Microbiology related events. Responsible to impart technical trainings to concerned staff related to Microbiology topics.Qualification & ExpeirenceM. Sc.Years of experience: 15 to 20 Years