We are currently looking for a Pharmacovigilance Quality Assurance Manager who will conduct the required audits for pharmacovigilance (PV) and support PV Audits and Inspections from Regulatory Authorities and Third Parties. This role will report to and coordinate with the Head of Pharmacovigilance Quality Assurance (Head PV QA).
Your responsibilities will include:
- Comply with all corporate policies, rules, and regulations as set out and communicated by the company pursuant to good business practice
- Independently conduct external & internal audits ( including affiliate, commercial partners, systems and vendor audits)
- Monitor audit responses and corrective action to ensure accuracy and completeness
- Auditing of directed and for-cause audits as necessary
- Audit documentation management and maintenance (including audit logs)
- Involvement in QM Clinical Medical Regulatory Safety (CMRS) audit, deviation and CAPA management (tracking, oversight, follow-up)
- Keep QM apprised of compliance and personnel issues
- Generate and provide metrics, status and other information in relation with GVP, as required by management
- Perform other duties as assigned, e.g. support of Head QM CMRS, Head PV QA , in
- Regulatory Authority inspection preparation, conduct and post-inspection activities
- Provide PV training to staff as well as special training groups from business and sales
- Write procedures, as well as monitor and assess global safety and clinical processes and procedures for consistency and with global laws, regulatory requirements and Vifor Pharma policies and procedures
The successful candidate has strong interpersonal and communication skills and is able to work independently as well as in a team environment. In addition you will require the following profile:
- Higher university degree (Masters) or equivalent in a relevant life sciences discipline (health sciences, nursing, pharmacy or related field)
- Minimum of 5 years of experience in Pharmacovigilance with FDA/EMA/ and ICH/GCP guidelines; monitoring and/or drug safety or clinical operations experience
- Previous experience in a pharmaceutical company or a Contract Research Organization within Quality Assurance / Compliance
- Proficiency in standard computer software (Word, PowerPoint, Excel) with a keen interest to database information on electronic systems and databases
- Fluency in English, both in oral and written communication; other major European language
(French, German, Spanish or Italian) would be an asset
- Readiness to travel up to 40%
We are looking for a strong communicator who can interact productively and effectively with peers, management and third parties. Furthermore, you demonstrate high ethical standards and integrity and proven ability to maintain a high level of confidentiality. You display flexibility and are able to use resources effectively and reasonably. Finally, your proven experience in a similar position will allow you to be successful in this position and in line with Vifor Pharma values.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The companys goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.
Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world.
The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are