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Full-time Physician, Drug Safety & Pharmacovigilance

at Santhera Pharmaceuticals in Basel CH

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of orphan mitochondrial and neuromuscular diseases.

In September 2015, our leading product Raxone® (idebenone) received European Marketing Authorization in the treatment of patients with LHON (Leber's Hereditary Optic Neuropathy). Raxone® is not only the first and only medicine approved for this condition, but it is also the first medicine approved for any mitochondrial disorder. The company currently develops Raxone® in other areas of high unmet medical needs, like the treatment of Duchenne Muscular Dystrophy (DMD) and Primary Progressive Multiple Sclerosis (PPMS). In addition, Santhera's pipeline includes omigapil, an investigational drug with anti-apoptotic properties, a compound in development to address unmet medical needs for patients with Congenital Muscular Dystrophy (CMD).

For more information, please visit the company's website www.santhera.com

We are currently looking to hire a:

Physician, Drug Safety & Pharmacovigilance

to be based at our Headquarters in Liestal, close to Basel.

Scope of Work

This position aims to put in place a role of senior global medical expert concerning the safety and risk profile of assigned products. It participates in and where applicable takes global leadership of operational, governance and advisory aspects of the medical management of safety data and the related drug safety, risks and benefitrisk profiles of assigned products. It ensures:

  • Adequate medical management of individual case reports (ICSRs)
  • Providing Global Medical Safety Expertise for assigned product(s)
  • Delivering contribution and advice as global drug safety expert for assigned products to Drug Safety Governance meetings and various other cross-functional team meetings

The scope of work of this position also includes the contribution to the efforts for continued optimisation of Santhera PV Systems.

The responsibilities for this role include the following:

A.

Medical management of individual case reports (ICSRs)

  • QC of ICSRs from a medical perspective, QC of MedDRA coding
  • Medical evaluation of ICSRs, including causality assessment, interpretation of ICSRs in the context of cumulative safety data, identifying cases of special interest, identifying cases needing immediate escalation within the Santhera Drug Safety and Pharmacovigilance governance structures.
  • Provide guidance on event selection and (MedDRA) coding (event, indication, drug) at individual case level and ensure related compliance with concerned current regulatory requirements. Ensure consistency of case handling from a medical perspective and of MedDRA coding across cases to enable effective and efficient data retrieval.
  • Provide sponsor/MAH input into and guidance on t...
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Published at 19-07-2017
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