Auftragsdetails

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 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:

• PhD, 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 year 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 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.***