PV Scientist Medical Writing – at Dr. Reddy’s, Apply Now!
Dr. Reddy’s Laboratories is hiring an experienced PV Scientist – Medical Assessment (Medical Writing) to join our Pharmacovigilance team in Hyderabad. If you have 3–6 years of experience in safety writing, regulatory documentation, and benefit-risk assessment, this role offers the opportunity to work in a global pharmaceutical environment. Help us shape the future of healthcare through impactful safety science and medical writing that supports patient safety and regulatory compliance.
Location: Hyderabad, Hyderabad, India
Employment Type: Full-time
Job Family: Medical Affairs & Pharmacovigilance
Sub Job Family: Pharmacovigilance
Years of Experience: 3 – 6
Company Description
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.
Main Responsibilities for Medical Writing:
- Signal management:
- Conduct signal management activities for assigned products, performing initial review of signal alerts, ensuring signal detection is conducted in a regular, timely manner in accordance with schedule. This may include interaction with the LifeSphere Signal Management System and/or review of outputs generated from the system.
- Aggregate Reports
and RMPs:
- Contribute to the scheduling of aggregate reports, RMPs and other safety related documents to ensure all required reports are documented on the report calendar. Maintain and harmonize global trackers for all aggregate reports across the regions
- Preparation of aggregate reports including: PSUR, PBRER, PADER, Annual Reports, DSURs, ACOs. Conduct peer quality review of aggregate reports, and quality review of reports generated by the vendor and by internal resources. Ensure all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements
- Prepare RMPs and contribute to REMS activities as required for Medical Writing
- Contribute to the implementation and tracking of additional risk minimization measures in collaboration with PV physicians, local affiliates and third party partners
- Prepare Health Hazard Evaluations and other ad hoc safety reports as requested
- Conduct benefit-risk evaluations under the supervision of PV physicians
- Clinical & Regulatory Activities: Provide safety input to other cross-functional documents, including clinical study protocols, study CRF, statistical analysis plan (SAP), coding review reconciliation, final study reports, dossier documents and other documents required to support filing activities. Participation in product/project team meetings.
- Provide safety input, advice and support to commercial, marketing and Medical Affairs activities as required for Medical Writing
- Labeling document review: under the supervision of PV physicians, provide medical input to reference safety information, Investigator Brochures, product labels and patient information leaflets to ensure the most up to date and accurate safety information is present in all labeling information
- Regulatory Authority query management: liaise with Regulatory Affairs to respond to PV –related Regulatory Authority queries; coordinate with various stakeholders when finalizing the response, ensure responses are tracked to closure
- Provide data for internal compliance meetings, monthly report and for inclusion in the PSMF as required
- Raise deviations to PV processes where identified for Medical Writing
- Participate in development of CAPA and take ownership of CAPA completion where assigned
- Participate in regular, scheduled meetings with PV team/service provider/third parties as required
- Initiate or support the development and revision of PV Medical Assessment SOPs and work instructions. Also participate in the review of cross-functional SOPs which include reference to PV Medical Assessment Activities.
- Support PV training for new members of PV team and non-PV personnel, particularly product-specific, scientific and medical training
Perform other ad hoc, PV related activities as requested by head medical assessment
Relationship Management
- Working within PV team and cross-functionally for Medical Writing
- Interactions with vendors/service providers for PV activities
Process Improvement / Standardization
- Participate in process improvement initiatives, as applicable
- Participate in safety database/PV system upgrade activities such as defining user requirements and conducting user acceptance testing
Desired Skills & Competencies
- Good working knowledge of PV regulations including FDA, EU & local requirements.
- Strong data analysis and report writing skills
- Excellent teamwork and interpersonal skills for Medical Writing
- Excellent time management and organizational skills
- Good knowledge of computer applications and software, including MS Word, Excel, PowerPoint etc.
M. Pharm (Pharmacology) or equivalent with 3 to 7 years of experience in pharmacovigilance with experience in writing and reviewing PV Medical Writing
Keywords: PV Scientist, Medical Assessment, Medical Writing, Dr. Reddy’s Laboratories, Pharmacovigilance, Hyderabad, India
