Clinical Medical Services Specialist
To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email [email protected]. Thank you! Pay Range: $35 to $40 an hour. Client Industry: Pharmaceutical Job Mode: 100% Remote Contract Duration: 12 Months Contract, with potential extension based on performance and business Job Summary: The Clinical Medical Services Specialist will support pharmacovigilance operations by collecting, evaluating, and processing clinical and post marketing adverse event reports. The role requires accurate case assessment and documentation in accordance with global regulatory requirements and established quality standards. The specialist will evaluate case seriousness, causality, and labeling requirements while managing initial and follow up assessments. The position plays a key role in maintaining compliance, data quality, and timely adverse event reporting. Key Responsibilities: Collect, assess, and process clinical and post marketing adverse event information in compliance with applicable global regulations. Perform seriousness assessments and causality determinations for adverse event cases. Conduct initial and follow up case evaluations and ensure accurate case documentation. Review applicable product labeling requirements during case processing. Maintain compliance with established procedures, quality standards, and productivity expectations. Stay current with pharmacovigilance practices, regulatory guidelines, and case processing requirements. Required Qualifications: Bachelor degree in a related health sciences field such as nursing, health sciences, or pharmacy, or relevant pharmaceutical industry experience may be considered in place of the specified degree. 2 to 4 years of relevant clinical experience, or two to three years of clinical experience combined with one year of pharmacovigilance experience. Pharmaceutical industry experience with clinical case processing. Working knowledge of ICH, FDA, EMA, and MHRA regulatory requirements. Proficiency in adverse event case processing procedures and documentation.
Preferred Qualifications
Experience with Veeva or similar pharmacovigilance systems. Experience supporting global drug safety operations and post marketing safety case processing. Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long term disability insurance, short term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually AS Applicable)