Medical Affairs jobs
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- SoteriusRemote
- Provide medical and PV oversight and input to Protocols, Investigator brochures,.
- Medical Review of aggregate reports (PBRER/DSUR/PADER) and related signal.
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- Salary Search: Global Medical Safety Physician salaries in Remote
- Statistical PharmaUnknown, Maharashtra
- Health insurance
- Internet reimbursement
- Regulatory Submissions: Preparing and submitting documents for product approvals to regulatory agencies (e.g., FDA, EMA).
- ProductLife GroupRemote
- MAIN ACTIVITIES FOR THE JOB.
- Contribute to regulatory activities performed on the RA Platform/the Hub.
- Regulatory activities include pre licensing activities,…
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- Salary Search: Regulatory Affairs Specialist salaries in Remote
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- ParexelDelhi
- An Associate must be technically competent and continually developing the skills as defined in the key accountabilities section of this document.
- View all Parexel jobs - Delhi jobs - Regulatory Affairs Specialist jobs in Delhi
- Salary Search: Regulatory Affairs Associate salaries in Delhi
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- Devine MeditechOkhla, Delhi, Delhi
- Health insurance
- Paid sick time
- Leave encashment
- Provident Fund
- Preparation and maintenance of EU MDR (2017/745) Technical Documentation.
- Preparation and review of CER, PMS, PMCF, RMF, GSPR, SSCP, DoC, and Technical Files.
- Noronic Pharmaceutical Pvt. Ltd.Gota, Ahmedabad, GujaratJob Description for RA (Regulatory Affairs – Pharmaceutical Company) · 1 to 5 Module · CTD/ ACTD · Process Validation (PV) · Stability · PDR · Art…
Regulatory Affairs Executive
Often replies in 3 daysGPC MEDICAL LTDDelhi, Delhi- Provident Fund
- 3–8 years of experience in Regulatory Affairs for medical devices.
- Familiarity with EU MDR 2017/745 and other international medical device regulations will be…
- Abbott LaboratoriesDelhi, Delhi
- Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
- Associates Degree (± 13 years).
- UL SolutionsIndia
- Previous medical device consulting experience.
- Leverage regulatory affairs experience gained in the medical device industry/medical device consulting area to…
- UL SolutionsIndia
- Previous medical device consulting experience.
- Leverage regulatory affairs experience gained in the medical device industry/medical device consulting area to…
- The Talent Keepers Private LimitedDelhi, Delhi
- Compliance & Regulatory Knowledge: Strong knowledge of regulatory and compliance frameworks governing medical affairs activities.
- GRAM HR SolutionsDehradun, Uttarakhand
- Ensure effective functioning of student support services, including hostel affairs, medical assistance, and special assistance programs.
- Professional UtilitiesNehru Place, Delhi, Delhi
- Paid time off
- Paid sick time
- Leave encashment
- Handle drug, cosmetic, and medical device registrations.
- Understanding of drug, cosmetic, or medical device approvals.
View similar jobs with this employerREBRACE PHARMACEUTICALS PRIVATE LIMITEDRanchi, Jharkhand- Health insurance
- Cell phone reimbursement
- Provident Fund
- Collaboration: Collaborate with cross-functional teams, including marketing, medical affairs, and regulatory affairs, to develop and execute promotional…
- PharmanoviaMumbai, Maharashtra
- Regulatory Affairs Associate – Full Time – Hybrid – Based in Mumbai or Vadodara – (3 days in the office and two days working from home).
- Vincit Labs PVT LTdDelhi, Delhi
- Strong knowledge of regulatory affairs principles, regulations, and guidelines, particularly in the relevant industry.
Job Post Details
Global Medical Safety Physician - job post
Remote
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Job details
Job type
- Full-time
Full job description
Brief Description of Duties:
This position is independently responsible to
- Medical Review of aggregate reports (PBRER/DSUR/PADER) and related signal
- management activities, screening scientific literature for the purpose of periodic submission as per the Regulations and SOPs.
- Contribute Medical Assessment for Aggregate Reports and HA responses for safety-related topics.
- Accountable for product Signalling data review, analysis and delivery in close collaboration with Product Leader. Ensure timely review, approval and communication of findings via governance fora.
- Contribute to content and participate in safety governance meetings and other external meetings as applicable (e.g., DMC, Adjudication Committee)
- Active and regular utilization of data review, reporting, and visualization tools and systems to support scientific activity
- Review, manage contribution of development of safety sections of regulatory documents and processes
- Assume RMP authoring ownership
- Collaboration with Safety Scientist, Medical Affairs and Regulatory counterparts
- on implementation and risk minimization measures
- Provide medical and PV oversight and input to Protocols, Investigator brochures,
- Safety summaries, Clinical study reports, Regulatory reports (periodic, ad hoc) • Generation/review of SOPs and WIs and execution of client and company SOPs
- Ensure compliance with project guidelines
- Maintain awareness of changes to/new regulations affecting PVG activities.
- Train and mentor new employees in aggregate reports writing and relevant
- pharmacovigilance activities (if required)
- To carry out necessary administrative duties required for the job.
- Other duties as assigned by management
- Builds and maintains good relationships across functional units and company
- affiliates.
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