Senior Specialist - Cedar Hills, UT, United States - Emerald Enterprises

Emerald Enterprises

Verified Company

Cedar Hills, UT, United States

2 weeks ago

Posted by:

James Miller

beBee Recruiter

Freelance

Description

Job Description:

Our team at Cedar Hills, UT is dedicated to pushing the boundaries of global healthcare through research and innovation in clinical research and pharmacovigilance.

We are committed to ensuring the safety and efficacy of our existing and pipeline products through clinical trials and surveillance, in order to produce safe, effective, and innovative medicine.

We are currently seeking a Senior Specialist (M/F/d) in Drug Safety / Pharmacovigilance to join our team in Munich on a permanent full-time contract.

Your responsibilities:

Execute local pharmacovigilance processes and activities
Provide support for Patient Support Programs (PSP) and/or Market Research vendor(s)
Ensure compliance with global and local SOPs and report any deviations or compliance concerns
Act as a Subject Matter Expert and support local PV audits and inspections
Participate in audits of contractual partners/vendors
Proactively identify procedural gaps and implement solutions in collaboration with stakeholders
Train local company staff, vendors, and business partners on PV processes and activities
Liaise with local business units to keep them informed of safety activities and provide input on strategic decisions
Manage adverse events cases, including intake and followup activities
Responsible for intake of cases received from designated point of contact, vendors, and business partners for Individual case safety reports (ICSRs)

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