Pharma Job Openings at Novartis, Investigator Post Vacant

Pharma Job Openings at Novartis, Investigator Post Vacant

Ph.D. in Pharmacology jobs. D Pharma jobs. Novartis invites applications with a diploma degree in Pharma for the post of Investigator, candidates having Experience in non clinical safety of marketed drugs and demonstrated and have the ability to lead work groups may apply for this job post. Eligible and Interested applicants can apply only for this job online. Check out all the details on the same below:

Job ID: 262323BR

Job Title: Investigator

Eligibility: PhD in pharmacology, toxicology or related biological science, PharmD or equivalent with a strong biological background

Experience: 5 years of experience in non-clinical safety aspects of marketed drugs

Skills:

  • Knowledge of drug development processes and worldwide regulatory guidelines and procedures
  • Documented expertise in scientific and technical problem-solving in an international, multi-disciplinary, project-driven environment.
  • Knowledge of applying in silico methodologies and applications (optional) \
  • Proficient with full range of techniques used in job and core area—especially with communication and interaction with global health authorities.
  • Ability to manage conflicting expectations in a matrix environment.
  • Proven negotiation skills.
  • Project management skills.
  • Team player behavioral attributes. 10. Self-motivated and able to operate independently

Job Description:

  • Compiles non-clinical safety contributions to PSURs, DSURs and Core Data Sheets of marketed products.
  • Participates in Global Project Team meetings and provides non-clinical safety contributions.
  • Addresses regulatory queries on marketed products
  • Establishes assessments of cytotoxic properties to guide drug production aspects.
  • Contributes to databases on toxicological profiles of impurities
  • Works directly with project teams to design and interpret nonclinical safety aspects of drug development, including decision analysis, regulatory acceptability and issue resolution
  • Identifies and communicates potential project hurdles; suggests solutions and establishes priorities and contingency plans in collaboration with the PCS line function management and project team members
  • Assures adequate support to all assigned tasks is optimal in terms of quality, timing and cost; negotiates these aspects with the line on behalf of the respective teams.
  • Assists in compiling, gaining endorsement of and updating function-specific development plans to support drug products.
  • Prepares scientific documentation relating to nonclinical safety aspects in collaboration with project team members for documents such as Investigator’s Brochure, Marketing Authorization renewals and Health Authority briefing books. Is proficient in knowing / applying respective ICH and OECD guidelines.
  • Monitors timelines and objectives to align with agreed upon team goals
  • Participates in Safety sub-teams and line function teams; represents the PCS line function on internal boards and with third-party organizations such as partners and scientific organizations.
  • Maintains scientific and regulatory expertise in the fields of drug development and safety assessment.

Apply Online

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