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PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.
SUMMARY
Primary responsibilities include: Supporting the product complaint system through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.
FUNCTIONS
- Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
- Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
- Follow-up on corrective actions derived from investigations through completion.
- On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.
- Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
- May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
EDUCATION/LICENSES
- Doctorate degree or Master's degree and 3 years of directly related experience to the job or Bachelor's degree and 5 years of directly related experience to the job or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
COMPETENCIES/SKILLS
- Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must.
- Excellent written and verbal communication skills, including facilitation and presentation skills.
- Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups.
- Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.
- Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate, as necessary.
Some experience in investigations and complaints.
Highly computer literacy
Full Bilingual both in writing and speak
Fast Learner
PharmaLex is an Equal Opportunity Employer
Job Types: Full-time, Contract, Temporary
Benefits:
Paid time off
Referral program
Schedule:
8 hour shift
Day shift
Experience:
Complaints/Investigations: 5 years (Required)
Ability to Relocate:
Juncos, PR 00777: Relocate before starting work (Required)
Work Location: Hybrid remote in Juncos, PR 00777
