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Drug Safety Lead (Bogotá)

Company

Organon

Location

bogotá, Colombia

Type

Full-time

The Position

  • Leads signal detection, safety evaluation and risk management planning and activities for low‑medium complex, medicinal products and/or medical devices during clinical development and/or for established brands from a scientific perspective by active participation and contribution to, amongst others, the Organon Asset teams (when available), Risk Management Safety Teams (RMSTs), Safety Review Committee (SRC), LEAD/LAST and other safety related decision‑making governance bodies. Safeguard patient from harm.
  • Lead Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
  • Lead the safety contributions to integral regulatory submissions.
  • Ensure that appropriate safety objectives and risk minimization strategies are included in clinical development programs and shows confidence, credibility and influence at all levels of the organization.
  • Expert evaluati...

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