Job Description
We are seeking an Associate in our Pharmacovigilance team who will be primarily responsible for the support of the Pharmacovigilance (PV) Quality Management System and associated training.
The incumbent will be based in our Hyderabad office and report to Head Pharmacovigilance and Medical Affairs – North America
Roles & Responsibilities
- Drafting procedural documents including Standard Operating Procedures, Work Instructions and Guidance Documents to capture PV processes.
- Participate in the review, formatting and routing for review of procedural documents authored by other team members.
- Assist in the development of training materials for procedural documents as a mechanism for testing and documenting understanding.
- Support the development of training curricula for the global PV Team and affiliates, as applicable.
- Develop/deliver adverse event reporting training for non-PV internal teams and drug safety vendors on routine as well as annual basis.
- Perform and compile request for information (RFI) with PV data, adverse event collection, case processing, signal and risk management, clinical studies, PV safety concern/related issues, etc. The compilation of information to process PADERS.
- PADERS submission and publishing for all DRL products & acquired products.
- Regulatory correspondences by updating the PV shared drive labeling updates and send over to other PV stakeholders.
- Ensure provision of strategic information and complete PV Due Diligence for potential product acquisitions/divestitures and creation/modification of Safety Data Exchange Agreements.
- North AmericaProduct List for PV oversight including Master list, external & in-licensing products.Secondary Responsibilities:These responsibilities will be undertaken as needed to support the global PV Team
- Receive and independently triage adverse events received from other manufacturers via regular mail and/or dedicated mailbox and forward promptly for case processing.
- Responsible for compliance with executed Pharmacovigilance Safety Data Exchange Agreements (SDEA) and routine reconciliations.
- Support finance team in collating and processing multiple invoices from Safety as well as risk management program vendors.
- Maintains document security and integrity by filing the Pharmacovigilance documents in a secure room or sending indexed files to offshore archival.
- With minimal assistance, should be able to prioritize multiple projects, able to suggest solutions to complex issues, and delivers complete and accurate information within deadlines.
- Support North America and Global PV team with audits/inspection readiness.
- Perform all duties in accordance with Dr. Reddy’s business principles, corporate directives, SOPs and government and industry guidelines.
- Perform other relevant tasks as requested by management.
Qualifications
Educational qualification: Bachelor’s degree in pharmacy
Minimum work experience: 3-4 years of drug safety experience in pharmaceutical industry with knowledge of global pharmacovigilance regulations
Skills & attributes:
Technical Skills
- Working knowledge of ICH-GCP guidelines and global regulations for PV, including FDA, Health Canada and EU
- Experience in drafting SOPs and Work Instructions and assisting in the preparation of training materials and e.g. quizzes to test SOP understanding
- With minimal assistance be able to take necessary decisions by applying FDA, HC, ICH-GCP and GPVP standard regulations/guidance.
- Proficient in MS Office: Word, Excel, & PowerPoint
Behavioral skills
• Excellent communication skills needed to independently liaise with external (PV vendors) stakeholders as well as internal teams (i.e. RA, QA) to obtain necessary information for day to day PV activities
Additional Information
Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/