Safety Specialist, Pharmacovigilance Case Processing

About the role

ProPharma, a consulting firm supporting biotech, medical device and pharmaceutical companies, is looking for a Pharmacovigilance (PV) Specialist, Case Processing. The specialist manages individual case safety reports, assesses them at case level, writes medical narratives and submits expedited reports to regulatory authorities in line with internal guidelines, SOPs and safety regulations.

Key responsibilities

• Daily processing of adverse event cases (clinical trial and/or post-marketed), including MedDRA coding and determination of seriousness and expectedness.
• Follow-up activities such as identifying information to be collected.
• Create and review case narratives and provide client notifications as required.
• Support the development of training materials and training delivery.
• Flag concerns and discrepancies to the Principal PV Specialist and/or Manager, Case Processing.
• Keep up to date with global safety regulations for medicines.
• Peer review cases for quality, consistency and accuracy as needed.

Required profile

• Bachelor's degree in life sciences; an advanced degree, RN, RPh or PharmD is preferred.
• Two years of related work experience.
• Fluency in English and Swedish is a must.

Required skills

• Basic knowledge of pharmacovigilance.
• Strong verbal, written and interpersonal communication skills.
• Attention to detail, problem-solving and ability to work independently and in a multi-disciplinary team.
• Organization and prioritization skills.