Risk Management Plans Manager/Medical Information Center Manage

Please note that only selected candidates will be contacted.

For our Client in ROTKREUZ, we are looking for a RISK MANAGEMENT PLANS MANAGER/MEDICAL INFORMATION CENTER MANAGER (RMP MANAGER, MIC MANAGER), for a 12 MONTHS contract.

Duration: 16/07/2018 to 16/06/2019

Location: Rotkreuz

Workload 100%

Job purpose:

The Medical Information Center (MIC) is the entry point for all medical and scientific questions and issues for non-promoted brands. MIC is responsible for the provision of timely, accurate and balanced medical/scientific and technical information to external and internal customers, with MI to optimize patient outcomes. Manage MIC data bases (global and local), review standard answers on a regular basis, assure coordination and/or reconciliation with QA and DS&E in order to cross check Adverse Event Reporting and Quality complaints, set MI strategy. Drives and monitors the local implementation of global Safety Risk Management Plans (RMP) and local amendments to these plans as required.

Major Responsibilities for RMP:

1) Drives the local execution of the RMP for all Gen Med, Oncology Pharma and Vaccines products in the Swiss CPO:

- Ensures training of CPO staff (incl. Sales/Marketing staff, 3rd party etc.) involved in the implementation of the RMPs on general RMP principles and RMP product specifics
- Supports all CPO departments (as applicable) such as DS&E, Medical, ICRO (International

Clinical Research Operations), Sales/Marketing, HE&OR (Health Economics and Outcome
Research), to ensure alignment of all local functions in support of RMP commitment implementation

2) Manage/oversee CPO RMP commitment status tracking activities in COSTA (Commitment Status Tracking Application), including:

- Assuming role as site owner (SO)
- Coordination of local implementation of RMP commitments
- Monitoring of local compliance with RMP requirements
- Creation of local RMP commitments for local RMPs (if applicable)
- Ensures delegated task owners (TO) are trained in COSTA

3) Provides input as required by Global RMP Office, DS&E Management and QPPV on implementation status of local RMP commitments

4) As member of the Global/Regional RMP Network, provides input to global RMP Office and
CPOs/countries on:

- Specific local RMP needs as required by local Health Authorities
- Sharing best "local" implementation practices, processes and systems/tools
- Local feasibility of implementation of global RMP commitments as requested

Major Responsibilities for MIC:

- Set up and roll out MI Strategy
- Enhance customer focused MI according to the company's standards
- Receive inquiries from external stakeholders (physicians, pharmacists, patients) and internal departments (Medical, Marketing, Sales) regarding non promoted products.
- Forward inquiries of promoted products to responsible Medical Advisor/MSL.
- Quality check and review of BPI/CDS update implementation in the CPO in collaboration with DRA for non-promoted products.
- Respond to queries by providing answers directly, or by obtaining necessary information from appropriate data source. Review response with supervisor or Medical Expert as appropriate.
- Manage MI Databases: Review standard answers on a regular basis, do quality check of data bases and develop new standard documents as appropriate.
- Provide reports for reconciliation with QA and DS&E to detect potential adverse event reporting.
- Act as Medical Expert for established products of the therapeutic area in cooperation with the global Medical Expert.
- Additional responsibilities in the therapeutic area may also include depending on assignments the following: Responsibility for NP4 procedures (medical part) of the established product portfolio, responds to training needs of established products of external vendors.
- Coordinate training activities for MI database used by other associates (eg Medical Advisor, MSL).
- Coordinate administrative activities in MI
- Ensure management and maintenance of efficient MI filing and archiving system.
- Coordinate literature search activities for non-promoted products.
- Continued professional development via keeping up-to-date on trends and developments in the wider MI function, including information resources.
- Prepare a long-term plan for MI activities aligned with the needs of internal and external customers through annual analysis of customer needs.
- Ensure ongoing quality control of MI activities.
- Is core member of the Established Medicines Committee (EMC).
- Represent the company's MIC in Pharma Industry events to network and learn

General:

- Is obligated to report any Adverse Event or Technical Quality Complaint within 24h from the receipt to the DS&E Safety Desk or Complaint Coordinator in accordance to the valid local SOPs.

Candidate's Profile:

Linguistic background:

- LANGUAGE GERMAN & FRENCH ARE A MUST (WRITTEN & SPOKEN),
- ENGLISH B/C1

Work experience:

MUST-HAVES:

- PHARMACEUTICAL BACKGROUND
- CLIENT ORIENTATION
- KNOW-HOW IN DIFFERENT SYSTEMS, MUTLI-CLINICAL TOPICS (DIGITAL)
- KNOWLEDGE OF NATIONAL AND INTERNATIONAL REGULATIONS FOR PHARMACOVIGILANCE
- KNOWLEDGE OF PHARMACOLOGICAL AND MEDICAL TERMINOLOGY.
- Excellent communications, interpersonal and negotiation skills
- Quality and focus oriented
- Computer knowledge
- Additional educational requirements as may be man-dated by national requirements

Education: A degree in medicine, veterinary medicine, pharmacy, health discipline or life sciences

For further details please contact Aleksandra Sztajerowska: (see below)