Bayer Life Sciences Job Opening – Apply Online
Junior Benefit Risk Management Lead
POSITION PURPOSE:
The Junior Benefit Risk Management (BRM) Lead position belongs to the PV Regions Operations BRM and contributes to assure patients’ safety by complying with all PV Quality System Documents (QSDs) and national and international drug safety regulations and requirements.
The main purpose of the position is to ensure that Bayer Pharmacovigilance (PV) standards are met by performing and bringing expertise in PV benefit risk management activities.
YOUR TASKS AND RESPONSIBILITIES:
- Preparation of Aggregate Safety Reports, e.g. Periodic Benefit Risk Evaluation (PBRER) / Periodic Safety Update Reports (PSURs), Addendum Reports, Bridging Reports, etc.
- Preparation of Risk Management Plans (RMPs)
- Adapting global RMPs to local requirements
- Adapting global aggregate reports to local requirements
- Conducting local signal detection and management
- Supports handling of ad hoc NCA safety requests
- Supporting due diligence and new drug development process
- Participation in BRM related cross-functional projects
- Liaises with the Country PV Functions in relation to PV legislative in BRM area and aligns on requirements interpretation
- Collaborates with global functions to assure effective and standardized setup of BRM processes
- Supporting preparation, roll-out, and conduct of BRM trainings
- Supporting senior BRM team members in inspection and audit readiness preparation
- Ensures best practice, standardization, and high compliance rates in Pharmacovigilance to assure the safety of patients and of the company’s products
- Build and foster relationships through effective communication and collaboration between all internal and external stakeholders, while at the same time ensuring that the highest PV standards are maintained
- Ensuring a high company compliance rate with respect to current legislation, fulfilling the regulatory requirements, and following the company QSDs for all activities covered by the PV Regions Operations BRM department
WHO YOU ARE:
- Medical, pharmacy, or life science degree related to the area, preferably with 1-3 years’ experience in the pharmaceutical industry, especially in pharmacovigilance
- Fluency in English (written and verbal communication)
- Team worker, able to work under tight timelines
- Very good communication skills
- Excellent organizational skills with the ability to find solutions (technical and non-technical) in a complex global and multicultural environment
- Excellent time management, focused on meeting deadlines
- Ability to follow and adhere to procedures and to make process improvement proposals
- Independent problem-solving skills
- Knowledge of major concepts in data management and systems
YOUR APPLICATION
Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation, etc. We are committed to treating all applicants fairly and avoiding discrimination.
Location: India: Maharashtra: Thane
Division: Pharmaceuticals
Reference Code: 816250
Contact Us
+022-25311234
Keywords: Junior Benefit Risk Management Lead, Bayer Pharmaceuticals, Pharmacovigilance, Patient Safety, Compliance, Drug Safety Regulations. Bayer Life Sciences Job Opening – Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
