Pharmacology and Toxicology Manager - Sindan Pharma, part of Teva Pharmaceuticals
Tevapharm
Bucharest, RO
4 zile în urmă

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.

Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day.

We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.

We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.

This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Pharmacology and Toxicology Manager - Sindan Pharma, part of Teva Pharmaceuticals

Sindan Pharma, part of Teva Pharmaceuticals is hiring Pharmacology and Toxicology Manager to join R&D Ops Steriles team located in Bucharest, Romania.

  • ROLE : Your role is to ensure support for R&D team in early stages of product development and to coordinate the activities for development studies and the interactions with the CRO executing E / L studies, reviewing the protocol / reports, toxicological evaluation and integration of data for the particularities of each drug product;
  • writing and signing of Safety Risk Assessments, reviewing of Toxicological Statements provided from external sources.

    KEY RESPONSIBILITIES :

    General

  • Medical / Toxicological support for R&D team in early stages of product development (in regards to maximum daily doses, inactive ingredients and proposed drug composition acceptability, allowed dosages, critical assessment of biopharmaceutical properties, dosage form and strength, evaluation of pharmaceutical and therapeutic equivalence with reference drug product, comparable performance, impurities etc).
  • Coordinating the activities for development studies (clinical / non-clinical / in vitro characterization studies) needed for new submissions / Responses to Authorities;
  • providing scientific support for the studies initiated, reviewing the protocols, amendments and study reports, evaluation and interpretation of primary study data.

  • Toxicological support in regards to evaluation of chemicals encountered during drug product development (degradation products / impurities, residual solvents, extractable and leachable primary packaging, manufacturing components, elemental impurities, nitrosamines, extractable from filters etc);
  • Coordinating the interactions with the CRO executing E / L studies, reviewing the protocol / reports, toxicological evaluation and integration of data for the particularities of each drug product;
  • writing and signing of Safety Risk Assessments, reviewing of Toxicological Statements provided from external sources.

    Clinical / Nonclinical support :

  • Preparation / updates of Clinical / Non-clinical sections of the submission dossier (module 2.4; module 2.5; module 4, module 5;
  • module 1.5.2; Biowaiver Justification, signing Clinical / Nonclinical Expert declarations)

  • Providing the answers to the Deficiency Letters coming from Authorities in relation with the Clinical / Nonclinical parts
  • Toxicology support :

  • Detailed evaluation of all available safety and efficacy data on a molecule / chemical; summarization of relevant data and calculating the permitted daily intake (PDE) for various chemicals (APIs, excipients, residual solvents, extractable / leachable etc).
  • Preparing / Reviewing Toxicological Statements provided from external sources, in regards to Impurities, Extractable / Leachable, etc, based on a multivalent approach (literature data review, computer software simulators -ToxTree, exposure being assessed, metabolic fate, chemical structural alert, TTC concept , etc), issuing an opinion of their relevance on human exposure and their safety or risks.
  • Preparing Elemental Impurities Risk Assessment Report for the submitted projects
  • Preparing Nitrosamine Risk Assessment Report for the submitted projects
  • Preparing Toxicological Risk Assessment for Extractable Pall filters
  • THE IDEAL CANDIDATE SHOULD HAVE :

  • University degree in Medicine, Pharmacy, Chemistry, Biology or another relevant area with the field
  • 2 years of experience in toxicology will be a huge advantage
  • 3 years of relevant experience in pharmaceutical industry is considered an advantage
  • Must speak fluid English and be a proficient scientific
  • Competencies :
  • Leadership skills, strong ability of managing without authority
  • Analytical capabilities
  • Assertiveness
  • Teamwork skills
  • Excellent communication skills
  • Ability to work under pressure, sometimes with tight deadlines
  • Good knowledge of Microsoft Office platforms
  • WE OFFER :

  • An exciting and challenging job in an innovative, flexible and growing company
  • A team of young, hard-working, open-minded and friendly colleagues
  • Trainings in R&D field
  • Function

    Research & Development

    Sub Function

    Pharma R&D Project / Program Management

    Already Working TEVA?

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    Teva’s Equal Employment Opportunity Commitment

    Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

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