Senior Clinical Pharmacovigilance Specialist - REF11436F
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
The Senior Clinical Pharmacovigilance Specialist will manage individual case safety reports (serious adverse events, adverse events of interest and reports of pregnancy) through intake, documentation and processing. Additionally, they will perform initial case-level assessment of expectedness; confirms seriousness; composes accurate and thorough medical narratives and generates site queries for missing or unclear information. The Senior Clinical Pharmacovigilance Specialist ensures all cases meeting expedited regulatory reporting criteria are submitted to regulatory authorities in accordance with internal guidelines, SMPs, SOPs and applicable safety regulations. They will maintain distinctive quality and commitment as the operating philosophy in carrying out all processes, while continually seeking out ways to enhance customer service experience both internally and externally.
Essential Functions Include:
Individual Case Safety Report Processing
- Verify presence of minimum criteria and aware date.
- Perform initial assessment of reportability, including expectedness assessment.
- Communicate with the study medical monitor to confirm seriousness, expectedness and causality of each event.
- Confirm events and code using MedDRA.
- Identify information to be collected during follow-up site queries.
- Prepare written communications to obtain follow-up information from the reporting study site.
- Write case narratives for MedWatch/CIOMS/E2B forms and submit for review.
- Address client questions on individual cases.
- Complete client notifications as required for case management.
- Develop client-specific case processing work instructions and other documentation as needed for client-specific requirements.
- Other duties as assigned.
Qualified candidates must have:
- RN, RPh, PharmD
- Required: Current healthcare license for degree or equivalent from state or country.
- Required: 3 years of experience in an acute healthcare, community pharmacy, or pharmaceutical industry setting.
- Preferred: 2 years of experience in clinical operations.
- Preferred: Drug safety experience.
- Preferred: Experience working with safety databases.
- Proficient computer knowledge and computer keyboarding skills including intermediate proficiency with Microsoft Office Suite (Outlook, Word, Excel).
- Working knowledge of FDA guidelines for clinical drug safety surveillance.
- Excellent internal and external customer service skills.
- Strong verbal, written and interpersonal communication skills.
- Strong organization and prioritization skills with meticulous attention to detail.
- Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge.
- Able to work independently and collaboratively in a multidisciplinary team.
- Able to occasionally work extended and/or flexible schedule to meet client requirements.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***