Drug Safety Associate

Vor 4 Tagen

Zug, Schweiz Covis Pharma Vollzeit

**Role and Company Overview**

We are currently searching for a Drug Safety Associate to be responsible for processing and reporting individual case safety reports (ICSRs) received from all sources for investigational and marketed products. You will assist with internal process development and improvements. As needed, you will interact with HCPs, study sites, vendors, and other departments.

Founded in 2011, Covis Pharma is a private equity backed global specialty pharmaceutical company that markets therapeutic solutions in 50+ countries, for patients with life-threatening conditions and chronic illnesses. Our paramount concern is patient’s outcomes as we focus on improving the health of people with serious medical conditions. Apollo Global Management is the private equity sponsor of Covis Pharma.

If you are looking to be a part of a global, vibrant, and fast-growing organization, have a positive attitude, seeking career development and acceleration and are energized by being a part of improving the lives of the patient’s we serve, we are the perfect match for you.

**WHAT YOU CAN EXPECT TO DO IN THE ROLE**:
Reporting to the Drug Safety Manager, you will perform case processing activities including triage, data entry, adverse event extraction and ranking, selecting, or verifying the appropriate coding (using MedDRA and the WHO Drug Dictionary), narrative preparation, and case submissions. You will utilize your medical background and experience to integrate case-related information including medical conditions, lab results and procedures to write comprehensive SAE case narratives. You generate follow-up requests and contact reporters as appropriate to obtain missing case information and/or additional clarifications. You ensure that all required follow-up attempts for assigned cases have been completed.

You review source documents and ICSR information to verify accuracy, completeness, and consistency.You perform Quality Control on other team member’s work and works independently to prioritize workload. You are responsible for ensuring adverse event reporting compliance with Covis SOP’s, SDEA timeframes, FDA, EMA, ICH and other regulatory requirements. You will interface with external and internal partners (e.g., CROs, Regulatory Affairs, Clinical Operations, and Medical Affairs).

**FOR THIS ROLE YOU WILL NEED**:

- Pharm D, Bachelor’s degree in pharmacy, nursing, life sciences or equivalent. Master’s or other advanced degree in life sciences is a plus.
- Minimum of 6 months to 1 year of experience in pharmacovigilance/drug safety.
- Working knowledge of drug safety databases is required.
- Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing Safety reporting and processing for clinical trial and marketed product environments.
- Knowledge of guidance documents and regulatory requirements as applied to clinical trial and post-marketing adverse event reporting.

**OUR OFFER TO YOU**:
By joining Covis Pharma you will be a part of a dynamic and energized team with a vested interest in your personal and professional development. You will be able to provide input into impactful decisions and be a part of shaping our company’s future. The skills and business insight you gain will serve as an invaluable foundation toward developing your career with us. We offer opportunities for advancement and support this through multiple development channels.

Our inclusive company culture brings unique perspectives and embraces diversity of thought. We actively seek to hire and develop the best and brightest team members from all backgrounds ensuring our continued success into the future.

**GET TO KNOW US**:

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