Job Overview

The Project Lead - Pharmacovigilance position at DDReg presents an exciting opportunity to elevate your career in pharmacovigilance project management. As a vital member of our Project Management team, you will be the primary contact for clients, guiding project activities, and ensuring that projects are not only delivered on time and within scope, but also uphold the highest quality standards. Embrace this chance to make a meaningful impact in the field!

Key Accountabilities

• Providing oversight and direction for all pharmacovigilance services.
• Client Relations:
  • Acting as the primary liaison for clients and project teams.
  • Serve as the primary contact, maintaining excellent communication and relationships with clients and internal teams

• Ensure consistently high-quality work and client satisfaction through clear communication, regular updates, and proactive problem-solving.

• Project Management

• Develop project scope and objectives based on signed agreements, ensuring alignment with client needs and regulatory requirements.
• Plan and track project activities, ensuring deadlines and interim milestones are met. Provide regular updates to clients and management on project status.
• Coordinating with the project manager and cross-functional project resources.
• Assessing workload and coordinating with resource managers for planning.

• Supporting pharmacovigilance project setup and team training.

• Representing pharmacovigilance in client and project team meetings.
• Conducting team briefing meetings to ensure project understanding and communication.
• Ensuring delivery of high-quality pharmacovigilance work within agreed timelines.
• Monitoring quality and compliance for safety deliverables.
• Leading coordination of safety or medical information-related activities.
• Training and mentoring newly hired pharmacovigilance staff.
• Performing other activities as identified and requested by pharmacovigilance management.

Qualifications

• Experience: 3-4 years of previous Pharmacovigilance Project Management experience, preferably within a service provider or CRO environment.
• A Life Science or Biomedical background with a healthcare-related degree (e.g., pharmacology, biology, biotechnology, veterinary science).
• Skillset:
  • Proficiency in PV processes/regulations including but not limited to Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding
  • Excellent client-management skills, with strong communication and presentation abilities.
  • Proven time management, organization, and multitasking skills with a keen attention to detail.
  • Advanced verbal and written English proficiency (minimum B2 level).

Advanced knowledge of MS Office applications (Word, Excel, PowerPoint).

Job Overview: To plan and execute digital marketing campaigns and design, maintain and supply content for the DDReg’s websites. To develop digital marketing strategies to increase DDReg’s Global visibility, increase traffic to DDReg’s website, generate leads and execute the strategies with the help of Digital marketing team. Roles & Responsibilities

• Plan and execute all digital marketing, including SEO/SEM, marketing database, email, social media and display advertising campaigns
• Design, build and maintain DDReg’s social media presence.
• Measure and report performance of all digital marketing campaigns, and assess against goals (ROI and KPIs)
• Identify trends and insights, and optimize spend and performance based on the insights
• Brainstorm new and creative growth strategies
• Plan, execute, and measure experiments and conversion tests
• Collaborate with internal teams to create landing pages and optimize user experience
• Utilize strong analytical ability to evaluate end-to-end customer experience across multiple channels and customer touch points
• Instrument conversion points and optimize user funnels
• Collaborate with agencies and other vendor partners
• Evaluate emerging technologies. Provide thought leadership and perspective for adoption where appropriate
• Analyze digital data to draw key recommendations around website optimization
• Conduct social media audits to ensure best practices are being used
• Maintain digital dashboard of several different accounts
• Prepare emails to send out to customers
• Ensure that the brand message is consistent
• Optimise the business website to increase online traffic.

Education & Experience

• 5+ Years of Experience in Digital Marketing
• Experience executing paid social media campaigns
• Bachelor's degree in marketing or business or Life Science Degree with diploma in Business Management
• Proven working experience in digital marketing
• Incredible attention to detail
• Full understanding of all social media platforms
• Excellent Communication Skill
• Knowledge of content management systems

Knowledge, Skills and Abilities

• Highly creative with experience in identifying target audiences and devising digital campaigns that engage, inform and motivate
• Experience in optimizing landing pages, user funnels and A/B testing
• Solid knowledge of website analytics tools (e.g., Google Analytics, NetInsight, Omniture, WebTrends)
• Working knowledge of ad serving tools (e.g., DART, Atlas)
• Experience in setting up and optimizing Google Adwords campaigns
• Working knowledge of HTML, CSS, and JavaScript development and constraints
• Strong analytical skills, problem-solving abilities and data-driven thinking
• Up to date with the latest trends and best practices in online marketing and measurement
• Excellent writing skills and verbal communication abilities
• Attention to detail and ability to multitask and manage multiple projects
• Capable of identifying, attracting and engaging target audiences
• Proven marketing experience on different digital platforms
• Knowledge of email, newsletters, push notification and display advertising campaigns
• Ability to use SEO, SEM and marketing databases for promotional purposes

Seeking candidature of candidates with minimum 10 years of experience in Corporate Quality Assurance (CQA). CQA candidates from CROs preferred. Roles & Responsibilities

• Implement systems that allow DDReg to meet its commitment to quality and add value for the customers.
• Continuous review of working levels processes to ensure compliance wrt the working level SOPs set within the Company.
• Constant upgrade of the Standard Operating Procedures as per applicable guidelines.
• Single Point of Contact for audits by client and for inspections by Health Authorities.
• Participate in Audits/inspections to ensure quality, integrity, and compliance with respect to ISO and regulatory requirements.
• Identify training needs of the working level teams from a compliance perspective.
• Identify and assess potential risks to quality, business continuity plan and work with senior leadership to develop mitigation strategies.
• Participate in risk management activities across projects and processes.
• define quality standards for each function within the organization.
• stay updated with global corporate quality Assurance standards.
• Monitoring and reporting on the quality of systems compliances.

  Preferred Skills

• Quality check
• Reasoning and scientific skills
• Assessment skills
• Analytical and persuasion
• Good communication
• Collaborative working

Job Description

Job title	AGM/Senior Manager
Reports to	Director

Job purpose To Manage Regulatory Affairs for Emerging (RoW) Markets/Regulated Markets (Eu/US/Canada/Japan/UK/Australia)  in compliance to applicable regulations and guidelines. The responsibility include review of technical documents/dossiers, preparation and submission of Submission dossiers in CTD format, ePublish them (wherever applicable), response to queries, post approval life cycle management etc. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg. Duties and responsibilities

• Providing high-quality CMC review of technical documentation for regulatory filings to various markets – key market being Saudi & GCC, for DDReg clients
• Actively contribute to the development and implementation of regulatory strategies, processes and timelines for grant of MAs.
• Prepares and compiles new CTD dossiers, renewals and variations ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Manage multiple projects with the help of team, track the status of each project, provide update to management in a time bound manner, monitor efficiency of team members.
• Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
• Monitor competitive regulatory practices, and actively review internal and external factors to mitigate potential problems.
• Ensure that draft labeling complies with all applicable regulations and guidelines

Education & Experience

• Bachelor's or Master’s degree in Pharma
• Previous experience of minimum 7 years that provides the knowledge, skills, and abilities to perform the job.

Knowledge, Skills and Abilities

• Excellent technical data interpretation skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Location Gurgaon, Haryana (INDIA)  

Job Description

Job title	Software Development Team Lead
Reports to	Director

Responsibilities:

• Works closely with the Product Leads to have a solid understanding of business and product.
• Is accountable for the applications the Dev teams develop and assists with questions and PROD support when needed;
• Capable of understanding and contributing to the technical solution from design through to code level
• Able to analyze and evaluate technical risks within the scope of a project and make judicious recommendations;
• Define delivery phases of the project including activities, sub-activities, and milestones ensuring these are documented and used as the basis for the project event log, issues and risk log and any subsequent reporting
• Ensure awareness, involvement and support from the key stakeholders and participants by building strong project teams and maintaining robust communication on the project status throughout its life
• Works with Training department to communicate changes to internal and external users;
• Responsible for delivering projects on budget, on time, to requirements, and with high quality;
• Managing the delivery of multiple complex simultaneous system development projects from design through to release
• Should be competent presenting technical information to a range of audiences including non-technical audiences;
• Leads a team working on significant and critical projects. Provides both technical and team leadership and mentoring;
• Responsible for performance evaluations of team members and assisting in the compensation process;

Requirements:

• Comfortable with documentation and creating infrastructure diagrams;
• Comfortable communicating directly with clients;
• Git, Source Tree;
• Worked in an Agile environment;
• Healthcare IT experience;
• Understanding of SOA development;
• Ability to write quality unit tests;
• Possess strong understanding of traditional RDBMS and distributed computing;
• Development on Linux;
• Experience/Knowledge with Spark and Scala;
• Experience in Spring, Hibernate, REST, ORM, JPA;
• Experience with AGILE software development methodology;
• Understanding of repeatable automated processes for building the application, testing it, documenting it, and deploying it at scale;
• Experience/Knowledge in web and backend design and development;
• Experience/Knowledge in UI frameworks and libraries like jQuery, ReactJS, Play, or AngularJS.

Education and Experience:

• Bachelors degree in Computer or Information Science-related field required; Masters degree preferred.
• At least three years of related experience required.

Location: Gurgaon, India (On-Site)