Pharmacovigilance Scientist Aggregate Reports Jobs

ProPharma Group is an industry-leading, single-source provider of 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, the United Kingdom, India, Ireland, 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 Sr. PV Specialist, Aggregate Reports will be responsible for the preparation and review of aggregate reports as per guidelines and work instructions.

Essential Functions Include:

• Authoring and review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities.
• Authoring and review of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
• Authoring /Quality Review of Signal Management Reports.
• Performing literature search and validity check for the aggregate reports.
• Management and reconciliation of relevant process trackers.
• Subject matter expert (SME) along with training and mentoring of individuals.
• Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
• Generation of Line Listings (LL) from the safety database
• Providing reliable support for high-priority Ad-hoc activities.
• Interacting with appropriate client personnel to resolve issues related to the Aggregate reports as per clients’ policies.
• Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines.

Qualified candidates must have:

• Ph.D., M-Pharmacy/B-Pharmacy, Doctor of Pharmacy (PharmD) from PCI recognized University/College.
• Preferred: 2-5 years of experience in authoring ARs and at least 1-2 years of exposure to Quality review.
• Proficient computer knowledge and computer keyboarding skills.
• Proficient with Microsoft Office Suite (Outlook, Word, Excel).
• Strong verbal, written, and interpersonal communication skills.
• Strong organization and prioritization skills; able to multitask.
• Flexibility to adapt and meet fluctuating business priorities.
• Able to occasionally work extended and/or flexible schedules 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.