Associate Specialist, Drug Safety

hace 9 horas

Panama MSD A tiempo completo

**Job Description**:
Join our Team and support us to Invent for Life

We are currently recruiting an Associate Specialist, Pharmacovigilance. Under the direction of the applicable management, this role is responsible for undertaking specified Pharmacovigilance activities including projects with oversight by their manager or a designated area colleague. The activities (as delegated/assigned by their manager) may include but are not limited to:

- Assists with execution of local Pharmacovigilance processes and activities in collaboration with internal functional areas and external parties as assigned.
- Assists with day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with Pharmacovigilance procedures and country regulations.
- Assists with Individual Case Safety Report Health Authority submissions in accordance with company procedures and health authority requirements, when requested.
- Assists with aggregate safety report submissions to Health Authorities in accordance with company procedures and health authority requirements, when requested.
- Responsible for filing (electronic, paper), storage and archiving safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
- Participates in compliance activities and assists in coordinating the preparation of necessary corrective actions locally for late reports.
- Supports local Pharmacovigilance audits and inspections when requested.
- Supports self-inspections as required by Pharmacovigilance Legislations (where applicable).
- Responsible for reporting adverse experiences or events or product quality complaints associated with the use of our company products in compliance with corporate policies that apply.
- Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity.
- May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
- May be assigned responsibility for ensuring appropriate Pharmacovigilance language is included in country agreements, liaising with Alliance Managers as required, supporting local qualification/due diligence activities and compliance reviews, and assisting in maintenance of the business partner data tracking system.
- May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations.
- Support local implementation of applicable business continuity plans (as applicable).
- Performs other activities as requested by their Manager.
- May participate on special projects or rotational assignments within or outside as part of their professional development.

Education
- Bachelor's Degree ("Licenciatura") in Health, Life Science, or Medical Science.

Work Experience:

- A minimum one (1) year of experience in the pharmaceutical industry with a specific focus on safety and pharmacovigilance related activities.
- General knowledge of Adverse Events reporting requirements and relevant Pharmacovigilance regulations.

Job‐specific competencies & skills:

- Must be fluent in English (written and spoken) while proficient in local language.
- Effective communications, organizational, and time management skills.

**Who we are**

We use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world’s most challenging diseases.

**What we look for**

Here, you'll find rewarding opportunities, diverse experiences, and an unwavering commitment to ethics and integrity. You'll collaborate with a group of talented colleagues who share your sense of purpose. Our company will empower you to innovate, explore, and develop your full potential. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
Domestic

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
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