Sr/Officer - Aggregate Report Writing (PSUR,) @ Lambda Therapeutic

Job Description

Roles and Responsibilities

• Preparation of full PSURs (PBRER format), PADERs, Addendum to Clinical overview summary report, and Risk Management Plan as per GVP and / ICH guidelines
• Preparation of educational materials for additional risk minimization measures and additional PV activities
• Safety data analysis from line listing generated from Pharmacovigilance database for signal and risk evaluation
• Review of published literatures for new significant safety information,
• Review of safety data reported from clinical/non-clinical studies and safety variations
• Awareness of MedDRA coding and its terminologies
• Through awareness of good pharmacovigilance guidelines for EU, Non-EU, and other and RoW countries
• To ensure pharmacovigilance activities are carried out in accordance with company SOPs and applicable regulations / guidelines
• To provide support to other members of the pharmacovigilance team as required
• To ensure the provision of appropriate pharmacovigilance advice to clients and colleagues
• Assist in the development of appropriate standard operating procedures
• Any other tasks as requested as by line manager to meet the business requirements

Desired Candidate Profile

BPharma or Mpharma with 3-4 years of experience in Aggregate report writing

Perks and Benefits

Job Classification

Education

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0 - 1 Yrs 1 - 2 Yrs 2 - 3 Yrs 3 - 4 Yrs 4 - 5 Yrs 5 - 6 Yrs 6 - 7 Yrs 7 - 8 Yrs 8 - 9 Yrs 9 - 10 Yrs 10 - 11 Yrs 11 - 12 Yrs 12 - 13 Yrs 13 - 14 Yrs 14 - 15 Yrs 15 - 16 Yrs 16 - 17 Yrs 17 - 18 Yrs 18 - 19 Yrs 19 - 20 Yrs 20 - 21 Yrs 21 - 22 Yrs 22 - 23 Yrs 23 - 24 Yrs 24 - 25 Yrs 25 - 26 Yrs 26 - 27 Yrs 27 - 28 Yrs 28 - 29 Yrs 29 - 30 Yrs 30+ Yrs

Expected Salary (*)

Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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Accounting / Finance Advertising / MR / PR / Events Agriculture / Dairy Animation / Multimedia Architecture / Interior Design Astrology Automobile / Auto Ancillaries / Auto Components Aviation / Airline / Aerospace / Aeronautical Banking / Financial Services / Broking BPO / Call Center / ITeS Brewery / Distillery Broadcasting Cement / Building Material Chemical / Petro / Plastic / Rubber / Glass Consumer Electronics / Appliances / Durables Courier / Transportation / Freight Defence / Government Education / Teaching / Training Electricals / Switchgears Engineering / Construction / Cement / Metals Environment / Waste Management Export / Import / Trading Facility Management Fertilizers / Pesticides FMCG / Foods / Beverage Food Processing Furnishings / Ceramics / Sanitaryware / Electricals Gems / Jewellery Gifts / Toys / Stationary Government / Departmental Heat Ventilation / Air Conditioning Hotel / Restaurant Industrial Design Industrial Products / Heavy Machinery Insurance Internet / E-Commerce IT - Hardware / Networking IT - Software / Services KPO / Research / Analytics Leather / Leather Products Legal / Courts Logistics / Courier / Transportation Management Consulting / Strategy Manufacturing / Production Matrimony / Matchmaking Media / Entertainment Medical / Healthcare / Hospital Merchant Navy Metal / Iron / Steel MFI - Micro Finance Military / Police / Arms Ammunition Mining / Quarrying NBFC-Non Banking Financial Services NGO / Social Work Office Equipment / Automation Not Mentioned Paint / Art / Sculpture / Craft Paper / Wood Personal Care / Beauty Pharma / Biotech / Clinical Research Politics Power / Energy / Oil / Gas / Petroleum Printing / Publishing / Packaging Quality Certification Real Estate / Property Recruitment Services / RPO Religion / Spirituality Retail Security / Detective Services Semiconductors / Electronics Shipping / Marine Telecom / ISP Textile / Garments / Fashion Travel / Tourism / Hotels / Airlines / Railways Unskilled Labor / Domestic Help Veterinary Science / Pet Care Sports / Fitness / Beauty NBFC ( Non Banking Financial Services ) Manufacturing Travel / Tourism Medical / Healthcare FMCG / F/B Education / Training IT Services / Consulting Software Product BPO / Call Center BFSI Power / Energy Recruitment Services Pharma / Biotech Oil / Gas / Petroleum Banking Real Estate Financial Services Accounting / Auditing Square 1 Consulting Services Hiring For A reputed Chemical industry Consumer Durables / Electronics Media / Dotcom / Entertainment Engineering / Construction Investment Banking / Venture Capital / Private Equity Aviation / Airline Automation Export-Import / Trading Shipping Hospitality FinTech Automobile / Auto Ancillaries Others Printing / Packaging Broking Auto Components E-Learning Furnishings / Sanitaryware / Electricals Chemical / Plastic / Rubber / Glass 97 KPO / Analytics Sanskar HR Consultancy Services Hiring For Chemical Industry Emerging Technologies MFI ( Micro Finance ) Heat ventilation Air conditioning Heat ventilation Air conditioning Subhadra Jobs Consultancy Hiring For Bpo Industry Subhadra Jobs Consultancy Hiring For Bpo Industry Acme Services Private Limited Hiring For Beauty Skin Care Industry Semiconductors Semiconductors Mining Sanskar HR Consultancy Services Hiring For Manufacturing Industry Sports / Fitness AMOHA CONSULTING AND VENTURES PRIVATE LIMITED Hiring For Urgent | Hiring for Branch Sales Manager role in NBFC Industry for Navi Mumbai - 5.5 LPA (Micro LAP) Paint Railways Legal BPM / BPO IT Services / Consulting Leather Film / Music / Entertainment Retail BPO / Call Centre Recruitment / Staffing Software Product Electronic Components / Semiconductors Banking Medical Services / Hospital (Diagnostics) Electrical Equipment Facility Management Services Analytics / KPO / Research Medical Services / Hospital Biotechnology Accounting / Auditing Internet E-Learning / EdTech Insurance Education / Training Financial Services (Asset Management) Chemicals (Paints) Financial Services (Broking) Pharmaceutical / Life Sciences Financial Services FMCG (Tobacco) Investment Banking / Venture Capital / Private Equity Engineering / Construction Iron / Steel FinTech / Payments Telecom / ISP NBFC Printing / Publishing Travel / Tourism Consumer Electronics / Appliances Medical Devices / Equipment NBFC (Micro Finance) Chemicals Food Processing (Dairy) Internet (E-Commerce) Hardware / Networking Real Estate Emerging Technologies (Cloud) FMCG Industrial Equipment / Machinery (Construction Equipment) Miscellaneous Real Estate (Co-working) Gaming Management Consulting Hotels / Restaurants Beauty / Personal Care Advertising / Marketing Agriculture / Forestry / Fishing Automobile Industrial Equipment / Machinery Industrial Automation Gems / Jewellery Water Treatment / Waste Management Automobile (Automobile Dealers) Design Advertising / Marketing (Digital Marketing) Electronics Manufacturing (Electronic Manufacturing Services (EMS)) Power Courier / Logistics Building Material Metals / Mining Textile / Apparel (Fashion) Auto Components Clinical Research / Contract Research Emerging Technologies (AI/ML) Electronics Manufacturing Events / Live Entertainment Law Enforcement / Security Services Agriculture / Forestry / Fishing (Agri-tech) Food Processing Government / Public Administration Petrochemical / Plastics / Rubber Architecture / Interior Design Import / Export Packaging / Containers Courier / Logistics (Logistics Tech) Legal Industrial Equipment / Machinery (Machine Tools) Emerging Technologies Beverage Furniture / Furnishing Furniture / Furnishing NGO / Social Services / Industry Associations Beverage (Brewery / Distillery) TV / Radio Emerging Technologies (Nanotechnology) Sports / Leisure / Recreation Oil / Gas Defence / Aerospace Textile / Apparel (Yarn / Fabric) Building Material (Glass) Power (Wind) Textile / Apparel Aviation Content Development / Language Automobile (Electric Vehicle (EV)) Fitness / Wellness Railways Emerging Technologies (IoT) Military / Police / Arms / Ammunition Animation EmpowerHire Associates Hiring For Casting Forging industry Gaming Job Search Hiring For Manufacturing Industry Auto Components (Tyre) Emerging Technologies (Drones/Robotics) Power (Hydro) Food Processing (Meat / Poultry) Building Material (Ceramic) Animation / VFX Pulp / Paper Job Search Hiring For Reak Estate industry Fertilizers / Pesticides / Agro chemicals Defence / Aerospace Jobs Territory Hiring For Business Development Manager-Jewellery industry Ports / Shipping Government Department Sunergeo India Corporation Hiring For Manufacturing Industry AIM JOBS HR SERVICE Hiring For Garment Industry Zecruiters Jobconnect Private Limited Hiring For Taxtile Industry M-Corp Services Hiring For Leading Appliance Industry Client EmpowerHire Associates Hiring For Forging Industry Job Search Hiring For Financial Industry Transformatrix Global Private Limited Hiring For Banking Industry Aarvi Encon Limited Hiring For staffing industry Job Search Hiring For Pharma Industry IT Services u0026 Consulting Square 1 Consulting Services Hiring For a reputed manufacturing industry Power (Solar) Building Material (Cement) Emerging Technologies (AR/VR) Emerging Technologies (Cybersecurity) Textile / Apparel (Home Textile) Square 1 Consulting Services Hiring For a reputed leather industry Ports / Shipping (Shipbuilding) Ports / Shipping (Shipbuilding) Urban Transport Internet (OTT) Not mentioned Emerging Technologies (Blockchain) Emerging Technologies (Blockchain) Advertising / Marketing (Public Relations) Recruitment / Staffing Consumer Electronics / Appliances Textile / Apparel (Technical Textile) Matrimony Kavita HR Consultant Hiring For Healthcare beauty Industry Square 1 Consulting Services Hiring For chemical manufacturing industry Sharda Consultancy Services Hiring For Travel industry Job Search Hiring For Travel Industry JJ JOBS / TRAINING SERVICES Hiring For Automotive and Automobile Industry at Chennai Square 1 Consulting Services Hiring For chemical manufacturing industry. Orange Umbrella Hiring For Manufacturing Industry 96 Kavita HR Consultant Hiring For Beauty Industry Sharda Consultancy Services Hiring For US TRAVEL INDUSTRY O3Hire Hiring For Insurance industry Approach Hiring For Tyres Industry Prominent Consultant Hiring For Chemical Industry Square 1 Consulting Services Hiring For s manufacturing industry Square 1 Consulting Services Hiring For a manufacturing industry ATURS ENTERPRISES Hiring For Mechanical Industry Client Emerging Technologies (3D Printing) EmpowerHire Associates Hiring For Forging and casting industry

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Accounts / Finance / Tax / CS / Audit Agent / Agency Analytics & Business Intelligence Architecture / Interior Design Banking / Insurance Beauty / Fitness / Spa Services Content / Journalism Corporate Planning / Consulting CSR & Sustainability Engineering Design / R&D Export / Import / Merchandising Fashion / Garments / Merchandising Guards / Security Services Hotels / Restaurants HR / Administration / IR IT- Hardware / Telecom / Technical Staff / Support IT Software - Application Programming / Maintenance IT Software - Client Server IT Software - DBA / Datawarehousing IT Software - E-Commerce / Internet Technologies IT Software - Embedded /EDA /VLSI /ASIC /Chip Des. IT Software - ERP / CRM IT Software - Mainframe IT Software - Middleware IT Software - Mobile IT Software - Network Administration / Security IT Software - Other IT Software - QA & Testing IT Software - System Programming IT Software - Systems / EDP / MIS IT Software - Telecom Software ITES / BPO / KPO / Customer Service / Operations Legal Marketing / Advertising / MR / PR Pharma / Biotech / Healthcare / Medical / R&D Packaging Production / Maintenance / Quality Purchase / Logistics / Supply Chain Sales / BD Secretary / Front Office / Data Entry Self Employed / Consultants Shipping Site Engineering / Project Management Teaching / Education Top Management Ticketing / Travel / Airlines TV / Films / Production Web / Graphic Design / Visualiser Other Areas

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Keyskills:   aggregate report writing pharmacovigilance Medical Writing report writing